MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: 5912170 (b)(6)- integrip cc,cluster hole ø 50.The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was the cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 42 months after a total hip replacement procedure, the plaintiff may require a future revision procedure to address prosthesis wear.The plaintiff has also reported pain and suffering.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
B1 - fields are blank, no adverse event and no product problem.H6 - fields updated (removed failure of implant code 1924).
Additional Manufacturer Narrative
H3: the most likely cause for the revision reported due to early prosthesis wear could include a number of variables including use error, implant positioning, implant size selection, and patient factors.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh could also have contributed to the wear.However, this cannot be confirmed as the devices were not available for evaluation and no clinical data was provided.

• Brand Name: NV GXL LNR, +5LAT, 32MM G1-48/50MM 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19508803
• Report Number: 1038671-2024-01878
• Device Sequence Number: 7452185
• Product Code: JDI
• UDI-Device Identifier: 10885862024275
• UDI-Public: 10885862024275
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024

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: 06/28/2022
• Device Catalogue Number: 136-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided; 08/07/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/17/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male