MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: event occurred in (b)(6).
Event or Problem Description
It was reported that approximately 1 month post implantation, the patient experienced pain and was found to have a tibial bone fracture.The patient has indicated a possible revision, but one has not been confirmed yet.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device was reported under the incorrect manufacturing site mfr.The initial report was forwarded in error and should be voided.Please see 0001825034-2020-00490.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device was reported under the incorrect manufacturing site mfr.The initial report was forwarded in error and should be voided.Please see 0001825034-2020-00490.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL
• 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: 9622805
• Report Number: 3007963827-2020-00033
• Device Sequence Number: 524633
• Product Code: HSX
• UDI-Device Identifier: 00880304812703
• UDI-Public: (01)00880304812703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000601
• Device Lot Number: 64271273
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 60