MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH L-SERIES; BIPOLAR HEAD 44MM

Model Number	BP-2844
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): - cocr fem head 28mm -3.5 offset 12/14 (cat# 142-28-93 / lot# 55806002).
Event or Problem Description
As reported, this (b)(6) y/o active female experienced a implantation of the femoral head replacement for left femoral neck fracture was performed using novation tapered stem, bipolar cup, and metal head on (b)(6) 2014.The patient is now undergoing a right total hip arthroplasty revision due to proximal migration of the bipolar cup was observed by x-ray review.The procedure was on (b)(6) 2019 at post-operative 5-years and 9-months.At the time of the re-operation, the bipolar cup and the metal head was removed but a remarkable delamination wear that might be caused by oxidation was observed around the locking ring of the polyethylene bipolar liner.Patient¿s weight (b)(6) lbs, height 4¿7¿.Devices are to be returned for investigation.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of the patient¿s cartilage becoming worn resulting in proximal migration of the bipolar head.The observed wear of the polyethylene locking ring was likely the result of femoral neck impingement.Concomitant device(s): - cocr fem head 28mm -3.5 offset 12/14 (cat# 142-28-93 / lot# 55806002).

• Brand Name: ACUMATCH L-SERIES
• Common Device Name: BIPOLAR HEAD 44MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9591528
• Report Number: 1038671-2020-00004
• Device Sequence Number: 328001
• Product Code: KWY
• UDI-Device Identifier: 10885862104939
• UDI-Public: 10885862104939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K905370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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 Model Number: BP-2844
• Device Catalogue Number: BP-2844
• Device Lot Number: 51349014
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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
• Patient Age: 66 YR
• Patient Weight: 49