MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Joint Dislocation (2374)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had a right total hip arthroplasty.Subsequently, the patient was revised for the second time approximately 13 years later due to instability.The surgeon found the proximal cable fraying, non-union of the trochanter, and the trochanter impinging against the ilium superiorly, levering out anteriorly, leading to the anterior dislocations.The head and liner were revised, and one proximal cable was removed.The revision was completed without complication.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503204 lot# 2724106 biolox⮠delta, ceramic femoral head, xl, 㸠32/+7, taper 12/14.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed, with a subsequent revision for loosening.The patient began experiencing recurrent dislocations that were reduced.A second revision occurred due to instability, non-union, abductor dysfunction, and impingement.3 images reviewed and not submitted to mmi as there sufficient documentation of impression, contained within the medical records.Submission of images would not enhance the investigation.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: LINER STANDARD 32 MM I.D. FOR USE WITH 48 MM O.D. 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: 18277697
• Report Number: 0001822565-2023-03404
• Device Sequence Number: 15165227
• Product Code: LPH
• UDI-Device Identifier: 00889024123717
• UDI-Public: (01)00889024123717(17)260714(10)65039055
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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: 07/14/2026
• Device Model Number: N/A
• Device Catalogue Number: 00630504832
• Device Lot Number: 65039055
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 44 KG