MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 52MM O.D. SIZE II POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH II LINERS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Cat# 00875201036 36mm i.D.Size ii elevated rim liner use with 52mm o.D.Size ii shell lot#64671746.Cat#00625006520 bone scr 6.5x20 self-tap lot#j7058108.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the surgeon performed the tests with the evidence materials and requested the opening of the implants in question.After impaction of the metallic component, it was verified that it presented laxity in the acetabular cavity.Even using two screws to establish the fixation, the surgeon did not obtain a satisfactory result and decided to replace all the components.No adverse events have been reported as a result of the malfunction.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 device was returned for evaluation.As returned, scratches are seen in the inner surface.The device history record shows a 100 percent dimensional inspect on a cmm.All devices that were sent to finished goods inventory were conforming to print specifications.Medical records provided were not sent for further review due to poor quality.Review of the device history records identified no (related) deviations or anomalies during manufacturing.It was alleged the surgeon did not follow surgical technique.However, without additional information, a definitive root cause could not 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 event information available at the time of this report.

• Brand Name: 52MM O.D. SIZE II POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH II LINERS
• 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: 14345943
• Report Number: 0001822565-2022-01381
• Device Sequence Number: 12067382
• Product Code: LZO
• UDI-Device Identifier: 00889024150171
• UDI-Public: (01)00889024150171(17)311104(10)65292869
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875305201
• Device Lot Number: 65292869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Female