MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338668

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

Patient Problems Unspecified Infection (1930); Osteolysis (2377); Impaired Healing (2378); Subluxation (4525); Joint Laxity (4526)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent revision surgery due to a loose, infected femoral component.During this procedure the implanted liner was removed and a antibiotic spacer was put in place.The patient then underwent revision surgery, 5 or 6 weeks later, due to timeframe of 2-stage revision.The whole s&n set was removed and replaced.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, the reported loosening of the patient¿s implant was likely due to the bone deficiency related to his previous infection.However, review of the provided documentation does not provide insight into the root cause of the reported infection, nor the dislocated antibiotic spacer.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 as the reported infections were years after implantation and therefore likely hematogenously spread.The patient impact beyond the revision procedure and related post-operative healing cannot be determined.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.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 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.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10884170
• MDR Text Key: 217635130
• Report Number: 1020279-2020-06650
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556022214
• UDI-Public: 00885556022214
• Combination Product (y/n): N
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: 71338668
• Device Catalogue Number: 71338668
• Device Lot Number: 12FM08921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention