MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE F RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42558000602 2909064327 partial femur cemented size 6 right medial.42518200609 42518200609 partial articular surface left medial size f 9 mm thickness.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent left partial knee arthroplasty.Subsequently, patient experienced tibial head fracture after ppk, the doctor does not suspect that the implants are faulty.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of x-rays received.Evaluation report provided by third party confirms periprosthetic fracture of the medial tibial plateau in the setting of a medial unicompartmental arthroplasty with osteopenia.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays received.X-rays evaluation report provided by third party confirms periprosthetic fracture of the medial tibial plateau in the setting of a medial unicompartmental arthroplasty with osteopenia.Primary operative notes do not indicate any intra-operative complications.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.

Event Description

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

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE F RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10355400
• MDR Text Key: 201525451
• Report Number: 0001822565-2020-02742
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42538000602
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 12/02/2020
• Supplement Dates FDA Received: 08/19/2020; 12/04/2020
• 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: 86