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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 02/10/2019

Event Type  Injury  

Event 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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9186741
• MDR Text Key: 162328310
• Report Number: 1020279-2019-03630
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598004
• UDI-Public: 03596010598004
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 71332756
• Device Catalogue Number: 71332756
• Device Lot Number: 17JM09564
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR