MAUDE Adverse Event Report: EXACTECH, INC. BIPOLAR HEAD 53MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	BP-2853
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's hip was revised approximately 3.5 years post initial operation.The patient fell down and had dislocation of bipolar cup.Next day, this patient went to see a doctor and surgeon found out disassociation of femoral head from bipolar cup via imaging system when he performed a closed/manual reduction by using imaging system.In this situation, he decided to perform revision surgery and femoral head and bipolar cup were replaced to new ones.This femoral head came off this bipolar cup without disassociation of locking ring.
Additional Manufacturer Narrative
D10 - concomitants: (b)(6), 188-00-09 -wedge plasma s/o sz 9.H3: customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.The complaint device was evaluated, and the reported event was not confirmed.Operative notes and/or medical records were not provided for review of usage/technique.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; it may be due to soft tissue tension, implant positioning, the reported patient fall and/or implant selection.However, the failure could not be confirmed because relevant patient information, images, or radiographs were not provided.Dislocation is a known risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections was corrected: d4.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: BIPOLAR HEAD 53MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21364026
• Report Number: 1038671-2025-00849
• Device Sequence Number: 12866020
• Product Code: KWY
• UDI-Device Identifier: 10885862105028
• UDI-Public: 10885862105028
• 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: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 01/22/2023
• Device Catalogue Number: BP-2853
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/12/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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
• Patient Age: 72 YR
• Patient Sex: Male