MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 36MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 09/18/2018

Event Type  Injury  

Event Description

It was reported that during a revision hip, liner would not lock in.No injury or delay reported.Back up available.

Manufacturer Narrative

The associated r3 20 degree articular insert was not made available for evaluation.Therefore visual inspection and dimensional test could not be performed.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.This investigation could not determine a specific cause of failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical evaluation could not performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.However, no significant surgical delay or patient impact/harm was reported and the procedure was completed with a backup liner.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

Manufacturer Narrative

The implant initially reported was not the one been revised, but the one been implanted.Thus, no confirmation of the revised implant details was received.

Manufacturer Narrative

The associated r3 20 degree articular insert was not made available for evaluation.Therefore visual inspection and dimensional test could not be performed.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.This investigation could not determine a specific cause of failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical evaluation could not performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.However, no significant surgical delay or patient impact/harm was reported and the procedure was completed with a backup liner.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 20 DEG +4 XLPE ACET LNR 36MM X 58MM
• 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: 7962896
• MDR Text Key: 123663546
• Report Number: 1020279-2018-02146
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598745
• UDI-Public: 03596010598745
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization