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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 01/07/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 176085909
• Report Number: 3007963827-2020-00033
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812703
• UDI-Public: (01)00880304812703
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Weight: 60