MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR -3MM NECK; PROSTHESIS, HIP

Catalog Number	163668
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01222.D10: cat #: 51-107100/tprlc 133 mp type1 pps ho 10.0/ lot #: 2711338.Cat #: 30123204/g7 vit e high wall lnr 32mm d/ lot #: 65257097.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient experienced a left hip dislocation approximately eleven years post implantation.No revision has been reported to date.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The additional information does not change the outcome of the previous investigation.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
It was reported a patient dislocated approximately seven days post implantation due to a dislocation.The patient was instructed to maintain strict hip precautions and wear a knee immobilizer for two weeks.No revision has been reported to date.
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; g3; h2; h3; h6.Proposed component code: mechanical (g04) ¿ head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on medical records.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left hip pain, worse after physical therapy, left anterior hip dislocation.X-ray review showed that dislocation is confirmed.Loosening is not confirmed.No signs of loosening, wear, radiolucency, or other contributing factors.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.

• Brand Name: 32MM MOD HEAD COCR -3MM NECK
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16895697
• Report Number: 0001825034-2023-00969
• Device Sequence Number: 12251299
• Product Code: JDG
• UDI-Device Identifier: 00880304256637
• UDI-Public: (01)00880304256637(17)260129(10)927120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K942479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2023

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: 01/29/2026
• Device Catalogue Number: 163668
• Device Lot Number: 927120
• Was Device Available for Evaluation?: No
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/19/2023; 06/07/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/25/2023; 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White