MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 66 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent hip revision due to dislocation hours after initial procedure, as the cup needed to be repositioned.It was reported that no further information is available.
Additional Manufacturer Narrative
Cmp- (b)(4).G2: foreign: canada.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00234 and 0001822565-2023-00235.Visual examination of the provided picture identified the shell and locking ring were explanted and covered in bio-debris.The locking ring appears fractured.No further evaluation can be made from the provided picture.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event for the cup.Head and liner remain unknown.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.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 66 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16768335
• Report Number: 0002648920-2023-00079
• Device Sequence Number: 12361776
• Product Code: LPH
• UDI-Device Identifier: 00889024118300
• UDI-Public: (01)00889024118300(17)250930(10)62587360
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00620006622
• Device Lot Number: 62567360
• 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: 04/14/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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