MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUP POSITIONER; INSTRUMENT, HIP

Catalog Number	00626001800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to customs and financial policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).
Event or Problem Description
It was reported that during an initial hip procedure that during impaction of acetabulum the shell component inserter broke.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the device was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, the device was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.

• Brand Name: CUP POSITIONER
• Common Device Name: INSTRUMENT, 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: 12672336
• Report Number: 0001822565-2021-03058
• Device Sequence Number: 19192875
• Product Code: FZX
• UDI-Device Identifier: 00889024120136
• UDI-Public: (01)00889024120136(11)150507(10)63049290
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: EXEMPT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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 Catalogue Number: 00626001800
• Device Lot Number: 63049290
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 100 KG