MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Difficult to Insert (1316); Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : item#:42542007501; tibia fixed non-porous left size f; lot#: 64495998.Foreign : (b)(6).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.

Event Description

It was reported that total knee arthroplasty was performed with persona.The surgeon could not insert persona mc surface to tibia base plate and he disengaged the surface to clean space between the surface and the tibia base plate by saline.After that, he tried to insert the surface again but he could not.Subsequently, persona uc surface was used to complete the procedure.

Manufacturer Narrative

D11: associated products : item: 42542007501; tibia fixed cemented left size f; lot: 64495998.This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the dovetail feature exhibits damage (flared out).Device history record (dhr) was reviewed and no discrepancies were found.Per persona revision knee system ifu, it is stated do not use the persona revision femoral components or tibial plates with the persona cruciate retaining (cr), medial congruent (mc) or ultra congruent (uc) articular surfaces.Do not use the persona revision cck articular surfaces with the persona ps or cr femoral components.They are not designed to be compatible.Hence the root cause is attributed to off label use.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00400.

Event Description

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

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT
• 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: 10770192
• MDR Text Key: 214125192
• Report Number: 3007963827-2020-00287
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024469211
• UDI-Public: (01)00889024469211
• Combination Product (y/n): N
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512100710
• Device Lot Number: 64666577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1