OXINIUM FEM HD 12/14 36 MM +0

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS AND THAT THE LENGTH OF THE HIP REPLACEMENT WAS SHORTER THAN THE NON-OPERATIVE SIDE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) R3 0 DEG XLPE ACET LNR 36MM X 58MM WERE REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4) THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). ADDITIONAL INFORMATION: H6: TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS. H11:THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE PHOTOGRAPHS WERE REVIEWED, AND REVEALED THAT THE DEVICES ARE SCRATCHED AND SCUFFED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, ONE OF THE PROVIDED X-RAYS IS CONSISTENT WITH THE REPORTED DISLOCATION, AS THE HEAD IS OUTSIDE OF THE ACETABULAR COMPONENT. ADDITIONAL MEDICAL DOCUMENTATION WAS NOT PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED A CLINICAL ROOT CAUSE FOR THE RECURRENT DISLOCATIONS CANNOT BE CONFIRMED. HOWEVER, THE LEG LENGTH DISCREPANCY CANNOT BE RULED OUT AS A POSSIBLE CONTRIBUTING FACTOR. A REVIEW OF THE PRODUCTION ORDERS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. FOR THE FEMORAL HEAD A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED PART NUMBER OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. FOR THE LINER A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TOTAL HIP SYSTEMS REVEALS FOR PREOPERATIVE WARNINGS AND PRECAUTIONS THAT IMPROPER NECK SELECTION, POSITIONING, LOOSENESS OF ACETABULAR OR FEMORAL COMPONENTS, EXTRANEOUS BONE, PENETRATION OF THE FEMORAL PROSTHESIS THROUGH THE SHAFT OF THE FEMUR, FRACTURE OF THE ACETABULUM, INTRAPELVIC PROTRUSION OF ACETABULAR COMPONENT, FEMORAL IMPINGEMENT, PERIARTICULAR CALCIFICATION, AND/OR EXCESSIVE REAMING MAY INCREASE THE RISK OF DISLOCATIONS, SUBLUXATION, DECREASED RANGE OF MOTION, OR LENGTHENING OR SHORTENING OF THE FEMUR, WHICH MAY LEAD TO REVISION SURGERY. THE INTRAOPERATIVE WARNINGS AND PRECAUTIONS INDICATE THAT MUSCLE LOOSENESS AND/OR MALPOSITIONING OF COMPONENTS MAY RESULT IN LOOSENING, SUBLUXATION AND DISLOCATION. ADDITIONALLY, ECTOPIC BONE AND/OR BONE SPURS MAY LEAD TO DISLOCATION AND PAINFUL OR RESTRICTED MOTION AND PROPER POSITIONING OF THE COMPONENTS IS IMPORTANT TO MINIMIZE IMPINGEMENT WHICH COULD LEAD TO EARLY FAILURE, PREMATURE WEAR, DEVICE RELATED NOISE, AND/OR DISLOCATION, ALL OF WHICH MAY LEAD TO REVISION SURGERY. POSTOPERATIVE WARNINGS AND PRECAUTIONS HIGHLIGHT THE NEED OF WARNING PATIENTS AGAINST UNASSISTED ACTIVITY, PARTICULARLY USE OF TOILET FACILITIES AND OTHER ACTIVITIES THAT REQUIRE EXCESSIVE MOTION OF THE HIP, AS THEY MAY RESULT IN SUBLUXATION OR DISLOCATION. FINALLY, POTENTIAL COMPLICATIONS ASSOCIATED WITH TOTAL HIP ARTHROPLASTY SURGERY, PRIMARY OR REVISION INCLUDE AGGRAVATED PROBLEMS OF THE AFFECTED LIMB OR CONTRALATERAL EXTREMITY CAUSED BY LEG LENGTH DISCREPANCY, EXCESS FEMORAL MEDIALIZATION, OR MUSCLE DEFICIENCY. A REVIEW OF THE RISK MANAGEMENT FILES REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THESE PRODUCTS AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE INJURY, PATIENT CONDITION, OR ABNORMAL LOADING OF LIMB. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.