MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 48 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00771100700-femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 standard offset-64496778.00885100832-neutral liner 32 mm-63468929.00625006530-bone scr 6.5x30 self-tap-j6779178.00877503204- biolox⮠delta, ceramic femoral head, xl, 㸠32/+7, taper 12/14- 2993195.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03728.0001822565 - 2020 - 03730.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.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 patient underwent a left hip revision approximately 1-month post implantation due to subluxation, malposition, and instability.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g4; h2; h3; h6.Reported event was confirmed via operative notes and x-rays reviewed by a healthcare professional.Review of the device history record for the shell identified no deviations or anomalies during manufacturing related to the reported event.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 WITH CLUSTER HOLES POROUS 48 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10785759
• Report Number: 0001822565-2020-03727
• Device Sequence Number: 3644469
• Product Code: JDI
• UDI-Device Identifier: 00889024151314
• UDI-Public: (01)00889024151314
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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 Model Number: N/A
• Device Catalogue Number: 00875704801
• Device Lot Number: 64530774
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 56