MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS); PROSTHESIS KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical devices: all poly patella cemented 38 mm diameter catalog # 42540000038, lot # 64890063.Femur cemented posterior stabilized (ps) standard right size 12 catalog # 42500607402, lot # 63343265 stem extension tapered cemented 14 mm diameter +30 mm length catalog # 42557000114 lot # 65083945.Psn tib stm 5 deg sz h r catalog # 42-5320-083-02, lot # 64803187.Articular surface fixed bearing constrained posterior stabilized (cps) right 12 mm height use with tibia sizes g-h / ps femur sizes 10-12 catalog # 42522601012, lot # 63512474.Articular surface fixed bearing constrained posterior stabilized (cps) right 12 mm height use with tibia sizes g-h / ps femur sizes 10-12 catalog # 42522601012, lot # 64917547.Headless trocar drill pin 3.2 mm diameter 75 mm length catalog # 00590102000, lot # 64951871.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the device was opened for implantation in patient.When trying to insert with squeezer, the device would not sit on lateral side.Upon inspection of the device there was deformity on lateral portion.Another device was used to complete the procedure.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned devices shows that the dove tail is flared out and exhibit signs of use.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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: PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS)
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12293021
• MDR Text Key: 265551703
• Report Number: 0001822565-2021-02148
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42522601012
• Device Lot Number: 63512474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Age: 48 YR