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
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision hip, liner would not lock in.No injury or delay reported.Back up available.
Additional 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.
Additional 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.
Additional 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
• 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: 7962896
• Report Number: 1020279-2018-02146
• Device Sequence Number: 1488253
• Product Code: MBL
• UDI-Device Identifier: 03596010598745
• UDI-Public: 03596010598745
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/28/2019

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 Expiration Date: 04/17/2019
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 09/18/2018; 09/18/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 05/02/2019; 05/15/2019; 05/28/2019
• 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