MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE MM ELEVATED RIM LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the surgeon placed the definitive metallic acetabulum and the corresponding polyethylene liner.When positioning the femoral head, the shell and liner were released from the acetabular cavity.No additional information.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: country: brazil.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01751.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of photos.Visual examination of the provided pictures identified a liner seated within a shell, no other observations could be made from the provided image.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Upon reassessment of the reported event, the liner was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.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
Upon reassessment of the reported event, the liner was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.

• Brand Name: 32MM I.D. SIZE MM ELEVATED RIM LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14643467
• Report Number: 0001822565-2022-01752
• Device Sequence Number: 12192601
• Product Code: LZO
• UDI-Device Identifier: 00889024149830
• UDI-Public: (01)00889024149830(17)240930(10)64400680
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093846
• 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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00875201432
• Device Lot Number: 64400680
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CAT# 00875306001 LOT# 64974367 SHELL
• Patient Sex: Male