CMRH HEAD SZ. 20

Description of Event or Problem

IT WAS REPORTED THAT, AFTER AN ELBOW ARTHROPLASTY PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT WAS AT WORK DOING MANUAL LABOR AND THE PYROCARBON HEAD OF THE MODULAR IMPLANT ALLEGEDLY FRACTURED. HE AS USING A HAMMER WHEN THE INCIDENT OCCURRED AND STARTED FEELING PAIN AND INSTABILITY DUE TO THIS ISSUE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 IN ORDER TO EXCHANGE THE BROKEN IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

Additional Manufacturer Narrative

G5: PMA/510(K) # B5: DESCRIBE EVENT OR PROBLEM, D2A: COMMON DEVICE NAME, D2B: PROCODE, H6: HEALTH EFFECT - CLINICAL CODE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 (TYPE OF INVESTIGATION), H10 (ROI). H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE PHOTOGRAPHS WERE REVIEWED AND REVEALED THAT THE IMPLANT FRACTURED OFF INTO SEVERAL PIECES. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT THE PROVIDED UNDATED/UNIDENTIFIED ELECTRONIC PHOTOCOPIES OF X-RAY IMAGING APPEAR TO SHOW A FRACTURED MODULAR (HEMI) RADIAL HEAD WITH SOME DISPLACED FRAGMENTS JUST SUPERIOR OF THE JOINT SPACE. THE REPORTED MANUAL LABOR/USING A HAMMER LIKELY CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT IMPACT IS DETERMINED TO BE COMPONENT FRACTURE WITH THE ONSET OF PAIN AND INSTABILITY WHILE PERFORMING MANUAL LABOR ALONG WITH THE SUBSEQUENT REVISION. A TRANSIENT POST-SURGICAL RESTORATIVE PHASE WOULD BE ANTICIPATED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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 CARBON MODULAR RADIAL HEAD (CMRH) REVEALED THAT STRENUOUS LOADING, EXCESSIVE MOBILITY, AND ARTICULAR INSTABILITY ALL MAY LEAD TO EVENTUAL FAILURE BY FRACTURE OF THE DEVICE. PATIENTS SHOULD BE MADE AWARE OF THE INCREASED POTENTIAL FOR DEVICE FAILURE IF EXCESSIVE DEMANDS ARE MADE UPON IT. THIS HAS BEEN IDENTIFIED AS A WARNING. A REVIEW OF THE RISK MANAGEMENT FILE 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 THIS PRODUCT AND EVENT. ACCORDING TO THE IMPLANT AND INSTRUMENTATION MANUFACTURING SPECIFICATION, ALL IMPLANTS AND INSTRUMENTATION WILL BE 100% VISUALLY INSPECTED TO IDENTIFY ANY DAMAGED AREAS. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE 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. H6 (INVESTIGATION FINDINGS).

Additional Manufacturer Narrative

A2: AGE OR DATE OF BIRTH, A3: SEX, B5: DESCRIBE EVENT OR PROBLEM H6: HEALTH EFFECT - CLINICAL CODE.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A TSA PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT WAS AT WORK DOING MANUAL LABOR AND THE PYROCARBON HEAD OF THE MODULAR IMPLANT ALLEGEDLY FRACTURED. HE AS USING A HAMMER WHEN THE INCIDENT OCCURRED AND STARTED FEELING PAIN AND INSTABILITY DUE TO THIS ISSUE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 IN ORDER TO EXCHANGE THE BROKEN IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR 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 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.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A TSA PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT WAS AT WORK DOING MANUAL LABOR AND THE PYROCARBON HEAD OF THE MODULAR IMPLANT ALLEGEDLY FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 IN ORDER TO EXCHANGE THE BROKEN IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.