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

Model Number	ACUMATCH 15 DEGREE LINER 28MM SZ F
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 100-28-05, 0492493 - cocr femoral head 28mm +5mm neck; 112-01-04, 0441690 - acumatch cemented stem sz 4; 120-01-50, 0498785 - acumatch cluster cup porous coated 50mm; 120-65-25, 0469685 - bone screw 6.5mm dia x 25mm long; pc-14, 0465179 - stem centralizer 14mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, surgeon revised patient due to dislocating.Surgeon noted there was significant poly wear with minimal osteolysis on the acetabulum.A new liner was trialed in acumatch cup but the stability he wanted was not achieved.The cup was removed and new alteon cup was implanted.Patient hip was stable with new implants.Patient as left in stable condition.No additional information is available.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, g3, g7, h2, h3 and h6 have been updated accordingly.Section b5: additional information received indicates that on (b)(6) 2021 the surgeon removed the alteon cup because it never achieved initial fixation.He converted to a dual mobility smith and nephew cup and a new exactech femoral head.It was noted that additional screws helped achieve fixation this time.No additional information available including x-rays or explants.(h3) the evaluation noted that revision reported was likely the result prosthesis wear, possibly due to edge loading/impingement, patient conditions, instability, or any combination of the listed possibilities, and dislocation after being implanted for approximately 17.75 years.However, this cannot be confirmed as the devices and x-rays were not available for evaluation.The most probable root cause associated with the reported event of "dislocation" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• 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
• MDR Report Key: 12280792
• Report Number: 1038671-2021-00369
• Device Sequence Number: 11473334
• 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: 2003
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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: 07/19/2008
• Device Model Number: ACUMATCH 15 DEGREE LINER 28MM SZ F
• Device Catalogue Number: 132-28-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability