MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71332756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right hip closed reduction was performed due to superior femur dislocation of the femoral prosthesis out of the acetabular cup.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that the intraoperative findings of stained fluid may be consistent with findings associated with metal debris.However, without all supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of the reported clinical reactions cannot be confirmed, and it cannot be concluded that they were associated with a mal-performance of the implant.The post-revision dislocation is a direct result of the patient twisting his hip.The patient impact beyond the revision/ post-revision closed reduction pain and healing cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause of the reported event is likely a traumatic patient event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X MM56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9186741
• Report Number: 1020279-2019-03630
• Device Sequence Number: 2774924
• Product Code: MBL
• UDI-Device Identifier: 03596010598004
• UDI-Public: 03596010598004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71332756
• Device Catalogue Number: 71332756
• Device Lot Number: 17JM09564
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR