MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4); foreign source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.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 unknown flakes of foreign material were found inside the sterile packaging of an articular surface.Surgical procedure was delayed by two minutes.There is no additional information available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product confirmed the presence of two small white debris in the inner sterile cavity which had been opened during surgery as evidenced by the blood stains on the sealing flange of the cavity.The sealing flange also exhibited homogeneous glue remains.The two white particles were measured with tappi chart 25-2007-187-00-ey and did not exceed the quantity and 0.60 sq.Mm size acceptable per zwi 43.098.7 acceptance criteria [a total of two particles whose individual areas do not exceed 0.60 sq.Mm in size are acceptable].As the packaging was determined to be acceptable per zwi 43.098.7 acceptance criteria [a total of two particles whose individual areas do not exceed 0.60 sq.Mm in size are acceptable], a review of the device history records and a complaint history review were not required per (b)(4) rev.11 but were completed.No recall and no other complaints were associated with the reported part/lot combination.Review of the packaging determined that no failure was found as the product is within specifications.No further investigation or action is required after review.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: ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11064790
• Report Number: 3007963827-2020-00335
• Device Sequence Number: 2876587
• Product Code: MBH
• UDI-Device Identifier: 00889024236523
• UDI-Public: (01)00889024236523
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512200510
• Device Lot Number: 64281973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 04/20/2021
• 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