MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 32MM SZ G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	132-32-27
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right hip implant on (b)(6) 2008, and then experienced a revision surgical procedure on (b)(6) 2023, approximately 14 years, 5 months after initial implant.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
H10.D10.Concomitants - product information: (b)(6) 118-00-06 - p-ser 12/14 pf plasma collared sz 6; (b)(6) 120-01-52 - acumatch cluster cup porous coated 52mm; (b)(6) 148-32-93 - 12/14 zirconia head 32mm -3.5mm neck pending investigation.There is no other information available.
Additional Manufacturer Narrative
A2-3: added patient age, d.O.B.And gender b1-2: added product problem, added hospitalization d10: corrected to "see h11" g: corrected reporter name and email address h6: corrected clinical code to 1994 and added component code 734.Added investigation codes: 4114, 3221, 4315 respectively.
Event or Problem Description
It was reported via legal documentation that approximately 14 years, 5 months after initial implant, a patient underwent a revision of right total hip arthroplasty to address paint to pain to the right hip.Operative report finds right hip with poly wear to edge loading to acetabular component lipped liner.Intraoperative findings note the patient did demonstrate a well fixed appropriately aligned femoral stem, the acetabular component was well fixed.Cable was mobile and loose.The liner and femoral head components were revised.There were no complications.The patient was taken to the recovery room in stable condition.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2023-01142.

• Brand Name: ACUMATCH GXL 15DEG LINER 32MM SZ G
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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
• MDR Report Key: 18935071
• Report Number: 1038671-2024-00568
• Device Sequence Number: 15175235
• Product Code: LZO
• UDI-Device Identifier: 10885862023247
• UDI-Public: 10885862023247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2025

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: 04/10/2012
• Device Catalogue Number: 132-32-27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: Not provided; 01/02/2025
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 11/25/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2008
• 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-1728-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male