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

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	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cup positioner instrument wouldn¿t thread into the acetabular shell.Compared to other impactors of the same type on-site, the length of the threaded portion of this inserter appears shorter (with the shiny shell impactor cap on) which would explain why it wouldn¿t thread into a shell.Four minute delay in surgery while another impactor was obtained.No additional information is available.No adverse event to patient.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).The device was not returned to zimmer biomet for investigation.The product location is unknown.If the device is received a follow-up mdr will be submitted.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product identified strike plate shows indentations from previous uses.Nicks, gouges, and scratches are noted to the handle and body.Thread deformation is noted at the leading threads.The dhr was reviewed and no discrepancies related to the reported event were found.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 additional event information to report at this time.

• Brand Name: CUP POSITIONER
• Common Device Name: INSTRUMENT, HIPS
• 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: 14137175
• Report Number: 0001822565-2022-01072
• Device Sequence Number: 6291085
• Product Code: LXH
• UDI-Device Identifier: 00889024120136
• UDI-Public: (01)00889024120136(10)64394548
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 00626001800
• Device Lot Number: 64394548
• 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: 04/10/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• 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: Unknown
• 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: Unknown