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

Model Number	NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the germany competent authorities, the patient presented for several follow-up checks with persistent symptoms on the opposite side.The x-ray control revealed a clear decentering of the prosthetic head.The ct scan also showed osteolysis in the acetabulum as a sign of premature inlay wear.This was verified when the inlay was changed on (b)(6) 2023 to a vitd-hardened, specially approved inlay (novation xle, neutral liner group 3, 36 mm i.D).As part of the replacement operation, in addition to the inlay replacement, the firm socket integrity was determined as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and the replacement of the prosthetic head.The explants are currently in the laboratory doctor's office for microbiological examination using sonication.After the examination (14 days of long-term incubation).
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The prosthesis wear reported may have been due to a combination of the risk factors specified in the hhe, such as use error, implant positioning, implant size selection, patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential), the use of nylon vacuum bags without evoh, surgical approach, or any combination of these possibilities.However, this cannot be confirmed since the devices were not returned for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have resulted from use error, implant positioning, implant size selection, patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential), the use of nylon vacuum bags without evoh, surgical approach, or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LNR, NEUTRAL, 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18330501
• Report Number: 1038671-2023-02980
• Device Sequence Number: 17820667
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• 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: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-32-53
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 11/19/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 05/07/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROWN CUP INLAY NEUTRAL GR.3,32MM; CROWN CUP,CLUSTER-HOLE GR.56; CROWN CUP,CLUSTER-HOLE GR.58
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male