MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH 15 DEGREE LINER 28MM SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-28-06
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) 114-11-01 - acumatch p-series porous coated collarless size 1.(b)(6) 120-01-48 - acumatch cluster cup porous coated 48mm.(b)(6) c-28l - ceramic head 28mm +5mm neck.The product associated with the reported event is within the scope of recall z-1734-2022.However, there is insufficient information to evaluate whether the subject issue of the recall was a 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
Legal case ¿ usa (master case no.(b)(4)).Related (b)(4) lh rev 1.(b)(4) lh rev 2.It was reported that approximately 166 months after a total hip replacement procedure, the patient has experienced prosthesis wear, pain, swelling, instability, osteolysis.No further issues or complications were reported.No additional information is available." (b)(6) 132-28-06 - acumatch 15 degree liner 28mm sz f.***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does contain evoh and was not affected by the recall.

• Brand Name: ACUMATCH 15 DEGREE LINER 28MM SZ F
• 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 32563
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20193831
• Report Number: 1038671-2024-03462
• Device Sequence Number: 15173538
• Product Code: JDI
• UDI-Device Identifier: 10885862023018
• UDI-Public: 10885862023018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 12/15/2009
• Device Catalogue Number: 132-28-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 09/11/2024
• Date Device Manufactured: 12/17/2004
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown