MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: persona uc articular surface, catalog #: 42511200412, lot #: 63551546; persona cr femur tm, catalog #: 42502205601, lot #: 63417242; prolong nexgen patella, catalog #: 00597206626, lot #: 62257588; palacos r 1x40 single, catalog #: 00111214001, lot #: 87494700; palacos cement, catalog #: unknown, lot #: unknown.Customer has indicated product will not be returned as product remains implanted.The investigation is in process.Once the investigation is completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00846, 3007963827-2019-00056, 0001822565-2019-00847, 0001822565-2019-00848.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.Device remains implanted in patient.

Event Description

It was reported patient underwent left total knee arthroplasty.Subsequently, patient is experiencing difficulty walking, pain and a burning sensation.No revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Event Description

No further event information available at the time of this report.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT
• 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: 8372203
• MDR Text Key: 137243116
• Report Number: 3007963827-2019-00056
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• 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: 42532006401
• Device Lot Number: 63744321
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 66