MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X38MM; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: x11-180310 bi-metric/x por nc lat 10x130 791710, 650-1055 cer bioloxd option hd 28mm 3094893, 15-105054 m2a 1 pc shell 38mmx54mm 175500.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.
Event or Problem Description
It was reported that a patient underwent 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 was left intact, and all other components were revised.It was further reported that the patient required a second revision due to dislocation and infection.All components were replaced with an unknown antibiotic spacer.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
It was reported from legal allegations that a patient underwent 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 one month post implantation due to dislocation where the head and liner were exchanged.A third revision occurred due to dislocation and infection.All components were replaced with an unknown antibiotic spacer.
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 dislocation, with the third captured in this complaint.The patient was still experiencing dislocations and developed an infection.All products were revised with an antibiotic spacer placed.A definitive root cause cannot be determined for the dislocation.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level.Therefore, it is unlikely that the specified device caused any patient infection.This complaint cannot be confirmed.Medical records were not provided.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: VIVACIT-E DM BEARING 28X38MM
• 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: 18575064
• Report Number: 0001822565-2024-00236
• Device Sequence Number: 7852833
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)261115(10)65254383
• 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,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 Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 65254383
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 01/17/2024; 05/17/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 01/31/2024; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female