MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE C HIGH WALL LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 during total hip replacement using g7 cup, the liner had biological contamination with a hair inside the sterile package.Thirty minute delay in surgery while new liner was opened and wound lavage.No additional information is available.No adverse event was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, h2, h3, h6.Reported event was confirmed due to the review of photos.Visual evaluation of the provided photos found the product has been opened and contains biological material.A hair like debris was found.Medical records provided were reviewed and identified biological contamination (hair) is detected when installing acetabular liner.There were no further issues during the procedure.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as a review of the provided photos found the product has been opened by the customer.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: 32MM I.D. SIZE C HIGH WALL LINER
• 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: 14103337
• Report Number: 0001822565-2022-01001
• Device Sequence Number: 15045729
• Product Code: LPH
• UDI-Device Identifier: 00889024520417
• UDI-Public: (01)00889024520417(17)260627(10)65100279
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K190660
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 06/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 30123203
• Device Lot Number: 65100279
• 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: 03/31/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Unknown