MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN PK VE PLY LM SZ J 8MM; PROSTHESIS KNEE

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical products: psn pk cmt fem lm, catalog #: 42558000601 lot # 63571319.Psn pk cmt tib lm, catalog #: 42538000901 lot # 63877441.Report source: (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.Multiple mdr reports were filled for this event: 3007963827-2021-00174, 3007963827-2021-00175.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to pain and possible loosening of tibial prosthesis.Attempt for further information has been made, but no further information has been provided.

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.Visual evaluation of the provided pictures shows signs of being implanted.The femoral and tibial components have foreign material on the surfaces that are in contact with the bones.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates overall implant fit and alignment are maintained.Bone quality appears mildly osteopenic.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.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown.H6: type of investigation - device not returned is n/a which was reported on initial report.Visual evaluation of the returned device shows signs of being implanted and bone cement remains.The additional information received doesn't change the previous investigation.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: PSN PK VE PLY LM SZ J 8MM
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12347471
• MDR Text Key: 267431972
• Report Number: 0001825034-2021-02435
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42-5182-009-08
• Device Lot Number: 63908005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 114 KG