MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) 180-01-56 - crown cup,cluster-hole.
Event or Problem Description
As part of the manufacturer's recall campaign, the patient presented for a check-up.The x-ray and ct check showed a clear decentering of the prosthesis head, a sign of osteolysis in the acetabulum an inlay wear.This was possible when the inlay was changed to a vitd-hardened one on (b)(6) 2024 specially approved inlay (novation xle +5mm, lateralized liner, group 3, 36 mm i.D., ref (b)(4), sn (b)(6)) be verified.As part of the replacement operation, in addition to the inlay replacement, the firmness was determined, cup integrity as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.
Additional Manufacturer Narrative
H2: no devices were returned for evaluation and no radiographs, images, operative notes, or patient medical history information were provided for review.It is possible this event is associated with polyethylene wear for which a number of variables including use error, implant positioning, implant selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) can be contributors.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh (subject of the associated fsca 18832/21) could also contribute to wear.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: implanted with a lateralized liner.The most likely cause for the reported revision due to prosthesis wear and osteolysis is a combination of the risk factors specified in the hhe.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.
Event or Problem Description
As part of the manufacturer's recall campaign, the patient presented for a check-up.The x-ray and ct check showed a clear decentering of the prosthesis head, a sign of osteolysis in the acetabulum an inlay wear.This was possible when the inlay was changed to a vitd-hardened one on (b)(6) 2024 specially approved inlay (novation xle +5mm, lateralized liner, group 3, 36 mm i.D., ref 146-36-53, sn (b)(6)) be verified.As part of the replacement operation, in addition to the inlay replacement, the firmness was determined, cup integrity as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.

• Brand Name: NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19296677
• Report Number: 1038671-2024-01187
• Device Sequence Number: 17559225
• Product Code: JDI
• UDI-Device Identifier: 10885862024299
• UDI-Public: 10885862024299
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 05/24/2022
• Device Catalogue Number: 136-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male