MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH MULTI HOLES 60 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Osteopenia/ Osteoporosis (2651)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat#00-4894-058-10 acet agmt sz 58 x 10 lot#63129477, cat#00-6250-065-25 bone scr 6.5x25 self-tap lot#64206965, cat#00-6250-065-40 bone scr 6.5x40 self-tap lot#64005644, cat#00-6250-065-50 bone scr 6.5x50 self-tap lot#63451417, and cat#00-6624-065-50 bone scr 6.5x50 self-tap lot#63759097.Report source: foreign country: (b)(6).The device will not be returned for analysis, per hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01502.
Event or Problem Description
It was reported that a patient underwent a hip revision approximately 20 to 30 years later due to poly wear and lysis.Subsequently, patient was revised approximately three (3) years later due to fracture, lysis, and pelvic discontinuity.Unfortunately the bone loss was too much for the tmars construct to support.A custom cage was created to reconstruct the acetabulum.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4: udi number; h2; h3; h6 visual examination of the provided picture identified the shell explanted and covered in bio-debris.No further evaluation can be made from the provided picture.Pictures were not provided of the liner.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.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 event information available at the time of this report.

• Brand Name: SHELL POROUS WITH MULTI HOLES 60 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14460978
• Report Number: 0001822565-2022-01503
• Device Sequence Number: 14611779
• Product Code: KWZ
• UDI-Device Identifier: 00889024118980
• UDI-Public: (01)00889024118980(17)280331(10)63835092
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 06/27/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00620206020
• Device Lot Number: 63835092
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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: Female
• Patient Weight: 80 KG