MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 21CM DIAPHYSEAL SEGMENT; PROSTHESIS, KNEE

Catalog Number	150473
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	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon opened the implant, there was a black oil residue on the plastic bag inside the blister.The implant did not have any residue on it, however, the surgeon cleaned the implant, and it was used for the surgery.It remains implanted.The patient has not experienced any post-op issues.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4) g2: foreign country: japan.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.The event is confirmed.Visual evaluation of the provided photos and returned product found black staining on the device pouch and on the inside of the device carton.Analytical testing concluded the staining is consistent with ti-6al-4v alloy (high carbon content particles and other mixed organic substance/contamination consisting of carbon, oxygen, silicon and traces of sodium, calcium and iron).The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause of the reported event can be attributed to a manufacturing issue.Upon reassessment of the reported event, it was determined to be not reportable.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSS 21CM DIAPHYSEAL SEGMENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22087681
• Report Number: 0001825034-2025-01497
• Device Sequence Number: 15459507
• Product Code: JDI
• UDI-Device Identifier: 00880304239944
• UDI-Public: (01)00880304239944(17)260818(10)385030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/10/2025

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: 08/18/2026
• Device Catalogue Number: 150473
• Device Lot Number: 385030
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown