MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE JJ ELEVATED RIM LINER USE WITH 54MM O.D. SIZE JJ SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.The 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 the liner fins broke off while impacting into the cup.All pieces were accounted for, and proper technique was utilized.The surgeon successfully impacted a new liner in place.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
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.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 related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d9; g3; h2; h3; h6 visual examination of the returned product identified inner spherical surface shows scratches from attempted use.Anti rotation scallops have deformation damage on the underside from attempts to seat the liner in the shell.One scallop has split and shows deformation as well on the underside from impact.Elevated rim has gouge and tool mark damage on the wall side down to and under the lip that seats against the shell.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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 further information at the time of this report.

• Brand Name: 36MM I.D. SIZE JJ ELEVATED RIM LINER USE WITH 54MM O.D. SIZE JJ SHELL
• Common Device Name: PROSTHESIS, HIP
• 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: 18363062
• Report Number: 0001822565-2023-03626
• Device Sequence Number: 8108997
• Product Code: JDI
• UDI-Device Identifier: 00889024149755
• UDI-Public: (01)00889024149755(17)271220(10)65643121
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875201136
• Device Lot Number: 65643121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 05/22/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/11/2024; 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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
• Patient Sex: Unknown