MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 7 yrs postop the initial rtha, this (b)(6) y/o female patient presented with a grossly unstable hip.Surgeon believes it was because of significant poly wear.Patient received an xle version of the same poly.The device will not be returned due to hospital policy.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, g3, g7, h2 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of prosthesis wear of the acetabular liner.The prosthesis wear may have been a result of orientation of the acetabular cup, edge loading/impingement, and/or patient related conditions.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not available for review.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12224896
• Report Number: 1038671-2021-00354
• Device Sequence Number: 14509915
• Product Code: JDI
• UDI-Device Identifier: 10885862024732
• UDI-Public: 10885862024732
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2017
• Device Model Number: NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP
• Device Catalogue Number: 138-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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: Required Intervention; Disability
• Patient Age: 79 YR
• Patient Weight: 75