MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT LEFT 13 MM; PROSTHESIS, KNEE

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	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the poly package had hair in it.No additional information according to the per.
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.Visual evaluation of the returned product found the sterile blister was opened.A hair-like foreign debris and a red-brown stain were identified in the sterile packaging.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.This complaint was confirmed by evaluation of the returned device(s).As the product was returned opened, it cannot be confirmed when or how the foreign debris and stain were introduced to the sterile packaging or the conformance of the product when it left zimmer biomet, therefore, a definitive root cause cannot be determined.A capa was previously initiated for the reported event.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT LEFT 13 MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11947919
• Report Number: 0001822565-2021-01585
• Device Sequence Number: 1058473
• Product Code: MBH
• UDI-Device Identifier: 00889024469327
• UDI-Public: (01)00889024469327(17)250929(10)64898417
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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 Expiration Date: 09/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 42512100813
• Device Lot Number: 64898417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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