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	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 01284, 0002648920 - 2022 - 00114, 0002648920 - 2022 - 00115.
Event or Problem Description
It was reported that an acetabulum 52 was opened, and at the time of placing liner 36, it did not fix inside the acetabulum, so a new liner 32 was opened because the medical team thought that liner 36 was defective.When they used the liner 32, it didn't fix it in the acetabulum either.The doctor took out the 52 acetabulum and tested both liners outside the patient, and neither one of them fixed inside the acetabulum.They had to open the 54 acetabulum and the 36 liner to finish the surgery.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.
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: h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It was stated the products were able to seat together when returned to the distributorship.However, as no pictures were provided, the devices were not returned, and it is unknown why the devices did not seat together during surgery, a 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.

• 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: 14287552
• Report Number: 0001822565-2022-01284
• Device Sequence Number: 14833722
• Product Code: LPH
• UDI-Device Identifier: 00889024150171
• UDI-Public: (01)00889024150171(17)301215(10)64818533
• 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): 05/18/2022

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: 64818533
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• 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
• Patient Sex: Female