MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	132-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Synovitis (2094); Implant Pain (4561)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 3733362 180-65-30 - alteon 6.5mm screw, 30mm, 4029458 180-65-15 - alteon 6.5mm screw, 15mm, 4305093 142-36-00 - cocr fem head 36mm +0 offset 12/14, 4392144 101-05-30 - 3.2mm drill bit30mm 1pk.
Event or Problem Description
It was reported that this female patient's left hip was revised 6 years post op due to polyethylene wear.X-ray revealed ¿evidence of significant polyethylene wear¿ and ¿evidence of osteolysis behind the socket.¿ defective gxl liner and femoral head were removed, and she was implanted with a new vitamin e 56/36 +10 degree novation xle acetabular liner and a 36 mm biolox delta femoral head.
Event or Problem Description
As reported via legal, that this female patient's left hip was revised 6 years post op due to polyethylene wear.X-ray revealed ¿evidence of significant polyethylene wear¿ and ¿evidence of osteolysis behind the socket.¿ the gxl liner and femoral head were removed, and she was implanted with a new vitamin e 56/36 +10 degree novation xle acetabular liner and a 36 mm biolox delta femoral head.No additional information.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported via legal, that this female patient's left hip was revised 6 years post op due to polyethylene wear.X-ray revealed ¿evidence of significant polyethylene wear¿ and ¿evidence of osteolysis behind the socket.¿ the gxl liner and femoral head were removed, and she was implanted with a new vitamin e 56/36 +10 degree novation xle acetabular liner and a 36 mm biolox delta femoral head.No additional information.
Additional Manufacturer Narrative
H3: investigation results - based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis: implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors.However, this cannot be confirmed because the device was not available for evaluation and images and radiographs were not provided.
Event or Problem Description
As reported via legal documentation, a patient had their first left hip revision surgery on (b)(6) 2016.They underwent secondary revision surgery on (b)(6) 2022, approximately 6 years after their preceding revision.(b)(6) 2022 operation report state that there was significant synovitis, but the femoral and acetabular components were found to be stable and appropriately positioned.The surgeon noted that there was an uncontained defect in the central dome, which was debrided.The patient tolerated the procedure well, without complication and transferred to the recovery room in a stable post- operative condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
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 review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from prosthesis wear/osteolysis as specified in the hhe: implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors specified in the hhe.However, this cannot be confirmed because the device was not available for evaluation and images and radiographs were not provided.

• Brand Name: NV GXL LNR, LIPPED, 36MM 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 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 3523771140
• MDR Report Key: 15626386
• Report Number: 1038671-2022-01319
• Device Sequence Number: 6184225
• Product Code: JDI
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2026

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: 07/01/2019
• Device Model Number: 132-36-53
• Device Catalogue Number: 132-36-53
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 12/22/2023; 04/14/2026
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/11/2022; 01/03/2024; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female