MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. 38MM O.D. SIZE C BEARING; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total hip arthroplasty.Subsequently, the patient was revised eighteen (18) years post implantation due to metal related pathology.During the revision, the initial stem and shell were left intact, and all other components were revised.It was further reported that the patient required a second revision due to dislocation.The head and liner were exchanged.No further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 15-105054 m2a 1 pc shell 38mmx54mm 175500 650-1067 cer option type 1 tpr sleve +3 3050930 650-1055 cer bioloxd option hd 28mm 3094893 customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility, and it was determined that the following implants/instruments are not compatible: dual mobility bearing and m2a shell.Medical records were not provided; however, the legal document was reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Since then, the patient has undergone multiple revisions, due to metal related pathology, and now this one due to dislocation.The head and bearing were revised.A definitive root cause cannot be determined.This complaint cannot be confirmed.Medical records were not provided for review.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: 28MM I.D. 38MM O.D. SIZE C BEARING
• Common Device Name: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18607269
• Report Number: 0001822565-2024-00325
• Device Sequence Number: 14133886
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)260819(10)65099298
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: Lay User/Patient
• Device Expiration Date: 08/19/2026
• Device Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 65099298
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female