MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA STEMMED CEMENTED TIBIAL COMPONENT LEFT SIZE B; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices - persona tapered cemented stem extension 14mm, catalog #: 42557000114, lot #: 64529921.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? investigation incomplete.
Event or Problem Description
It was reported that during knee arthroplasty, it was identified that the set screw packaged with the tibial component was missing from the packaging.As no replacement was available, the surgeon used the tibial component with a stem extension.No adverse events were reported as a result of this malfunction.Attempts have been made to obtain additional information, however, no additional information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.

• Brand Name: PERSONA STEMMED CEMENTED TIBIAL COMPONENT LEFT SIZE B
• 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: 10676592
• Report Number: 3007963827-2020-00247
• Device Sequence Number: 14191699
• Product Code: JWH
• UDI-Device Identifier: 00889024246638
• UDI-Public: (01)00889024246638
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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 Model Number: N/A
• Device Catalogue Number: 42532006101
• Device Lot Number: 63931231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/30/2020
• 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