MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE HH NEUTRAL LINER USE WITH 50MM O.D. SIZE HH SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00-7713-006-00 lot# 63304837 mod ml taper fem st 6, cat# 00-8757-050-02 lot# 63321604 continuum tm shell multi 50 hh, cat# 00-7848-023-01 lot# 62796946 kinectiv modular neck g1, cat# 00-8775-032-02 lot# 2855090 biolox delta head 12/14 32x0, cat# 00-6250-065-20 lot# 63373266 trilogy bone scr 6.5x20.G2: foreign ¿ japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation as return was not approved by the surgeon.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 by the surgeon that the patient underwent an initial hip procedure and was revised approximately seven years later due to suspected wear of the liner.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Visual examination of the provided pictures identified the liner to have 3 screw holes which are typical for removal of the liner from the shell.No wear was seen.No other information was obtained.A review of the device history records identified no deviations or anomalies during manufacturing.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: 32MM I.D. SIZE HH NEUTRAL LINER USE WITH 50MM O.D. SIZE HH 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: 17852734
• Report Number: 0001822565-2023-02664
• Device Sequence Number: 6890574
• Product Code: MBH
• UDI-Device Identifier: 00889024154940
• UDI-Public: (01)00889024154940(17)210228(10)63295362
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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): 01/19/2024

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00885100932
• Device Lot Number: 63295362
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown