MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT; 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	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implantation, a loose sliver of an object was retrieved.The surgeon remarked that this was adhered to the articular surface, and had to be removed from the surgical site with the use of an artery forceps.It was remarked by the surgical team that this could have been part of the articular surface (as a manufacturing defect), and may not have been part of the cement used.The cement used during the surgery was either palacos mv or smartset ghv.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Report source: foreign - (b)(6).The 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 product was not returned for evaluation.Visual evaluation of the debris returned found the debris fragment to be visually consistent with the packaging foam insert used during manufacturing.However, as the debris was found after the sterile packaging was opened, the origin of the debris cannot be confirmed or conclusively linked to the manufacturing process or transit damage.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was opened during surgery.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.
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.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10.The product was not returned for evaluation.Visual evaluation of the debris returned found the debris fragment to be visually consistent with the packaging foam insert used during manufacturing.The device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13169997
• Report Number: 3007963827-2022-00002
• Device Sequence Number: 13942052
• Product Code: MBH
• UDI-Device Identifier: 00889024237254
• UDI-Public: (01)00889024237254(17)250228(10)64792823
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K121771
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2022

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 42512400711
• Device Lot Number: 64680416
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 02/03/2022; 04/26/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/04/2022; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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: 63 YR
• Patient Sex: Male