MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 10 DEGREE ELEVATED RIM; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D1: liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell d10: 00771101220 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 extended offset 60702541 00620005822 shell porous with cluster holes 58 mm o.D.61237904 00625006530 bone scr 6.5x30 self-tap 61246409 multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2024 - 00067 0002648920 - 2024 - 00004 0002648920 - 2024 - 00005 product has been received by zimmer biomet and 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 the patient was implanted with zimmer biomet products on an unknown date.Subsequently, the patient was revised due to recurrent infections.Surgeon performed a debridement procedure and a complex closure.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified the liner was embedded in the shell and could not be removed.There was no visible damage to the liner.The outside radius of the shell had debris attached.The returned stem had debris attached and damage near the taper location.The taper of the stem had visible gouging.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.An adequate complaint history review cannot be performed as the complication, failure mode, and/or harm experienced by the user is unknown.Medical records were not provided for this revision.The most recent revision surgery does not state that the stem, shell, screw, and liner were explanted.The patient has a previous medical history of metal related pathology and infection.A definitive root cause cannot be determined.This complaint cannot be confirmed as the reason these were revised is unknown.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.

• Brand Name: LINER 10 DEGREE ELEVATED RIM
• 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: 18446545
• Report Number: 0001822565-2024-00069
• Device Sequence Number: 18057488
• Product Code: JWH
• UDI-Device Identifier: 00889024124813
• UDI-Public: (01)00889024124813(17)221130(10)63822644
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K972774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00631005836
• Device Lot Number: 63822644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2017
• 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 Sex: Male