MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE JJ NEUTRAL LINER USE WITH 54MM O.D. SIZE JJ SHELL; PROSTHESIS, HIP

Catalog Number	00885101132
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: japan.Concomitant medical products: cat #: 00875705401/54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners/lot #: 64904429.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 did not assemble correctly with the shell.A new liner was used and it fit into the shell correctly.There were no consequences or impact to the patient.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 following sections were updated/corrected.Updated: g3, g6, h2, h3, h4, h6 visual review of the returned liner confirms item and lot etch.Liner shows inner spherical surface is broken.Deformation, gouges, nicks, and scratches from attempted use.Damage is noted to all areas of the liner.A review of the device history records identified no deviations or anomalies during manufacturing.A review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.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 additional event information to report at this time.

• Brand Name: 32MM I.D. SIZE JJ NEUTRAL 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: 16265066
• Report Number: 0001822565-2023-00221
• Device Sequence Number: 14954175
• Product Code: OQG
• UDI-Device Identifier: 00889024154995
• UDI-Public: (01)00889024154995(17)260404(10)65015613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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 Expiration Date: 04/04/2026
• Device Catalogue Number: 00885101132
• Device Lot Number: 65015613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2021
• 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