R3 20 DEG XLPE ACET LNR 36MM X 58MM
Received Jun 12, 2026 · Event occurred May 20, 2026
Report 1020279-2026-00809 · MDR key 25494293
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Smith & Nephew, Inc.Catalog number
71335758
Lot number
24LM02914
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
- Swelling/ Edema
- Medical device site infection
Narrative
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE: CASE-(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.
Description of Event or Problem
IT WAS REPORTED THAT, AFTER THA HAD BEEN PERFORMED ON (B)(6) 2026, 4 WEEK POST-OP, THE PATIENT DESCRIBED PAIN AND SORENESS COMING FROM THE SURGICAL SITE. AFTER VISUAL EXAMINATION AND BLOODWORK DONE, IT WAS DECIDED THAT THE PATIENT HAD AN INFECTION OF THE JOINT AND REQUIRED A DEBRIDEMENT AND LINER EXCHANGE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2026 IN WHICH ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 58MM AND ONE (1) OXINIUM FEM HD (B)(6) 36 MM L/+8 WERE REPLACED. BLOOD CULTURES AND TISSUE SAMPLES WERE SENT FOR LABORATORY TESTING. ANTIBIOTICS WERE ADMINISTERED AND THE WOUND WAS IRRIGATED WITH LARGE VOLUMES OF SODIUM CHLORIDE, IODINE AND OTHER IRRIGATION SOLUTIONS TO REMOVE BACTERIA. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.