MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 12/14 TAPER; PROSTHESIS, HIP

Catalog Number	00801802202
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: spain.D10: cat #: p0560046 / avantage inlay s46 / 22,2 / lot #: 0001484704.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a hip revision approximately three months¿ post implantation due to a dislocation.The head and insert were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- head.No product returned or pictures provided; visual and dimensional evaluations could not be performed.This complaint could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d9; g3; h2; h3; h6.Visual examination of the returned product identified outside diameter of head has scratches and scuff marks.Internal taper has small spots of discoloration/staining.No other damage was noted during visual evaluation.The measured dimensions are conforming to specification.Root cause remains unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL HEAD 12/14 TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17297971
• Report Number: 0002648920-2023-00154
• Device Sequence Number: 14421677
• Product Code: LPH
• UDI-Device Identifier: 00889024144538
• UDI-Public: (01)00889024144538(17)260831(10)63436344
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2025

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: 08/31/2026
• Device Catalogue Number: 00801802202
• Device Lot Number: 63436344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 05/14/2025
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/23/2023; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown