MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE GH 12 MM HEIGHT "USE WITH PLATE 5; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products : kne-other-femorals-unk.Kne-other-tibial trays-unk.Report source: foreign : (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00517, 0001822565-2021-00518,.

Event Description

It was reported patient underwent knee arthroplasty about 12 years ago.Subsequently patient was revised for tibia loosening and instability.Surgeon noted pitting and wear in articular insert and moderate osteolysis.Surgeon requests implants be decontaminated and returned for inspection.No additional information is available.

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.The complaint for wear is confirmed, however loosening and instability cannot be confirmed.Visual examination of the provided pictures identified the components had been explanted, however the product identification cannot be seen.The articular surface shows sign of wear from being implanted.The femoral component shows signs of being implanted and bone growth remains on the implant.The tibial component shows signs of being implanted, however no bone growth or cement remain on the implant.Device history record (dhr) review was unable to be performed as the part/lot number of the device involved in the event is unknown.A definitive root cause cannot 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.

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 at the time of the initial medwatch.D11: stemmed tibial component item # 00598004702, lot # 61024587.Femoral component precoat size g left compatible with lps-flex prolong item # 00596001751, lot # 60999078.H6 - type of investigation - 4114 - device not returned & 4119 - insufficient information available is n/a which was reported previously.Visual evaluation of the returned device shows signs of being implanted scratched / foreign material on the distal surface of the femoral components.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: ARTICULAR SURFACE SIZE GH 12 MM HEIGHT "USE WITH PLATE 5
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11379821
• MDR Text Key: 233722837
• Report Number: 0001822565-2021-00516
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K173057
• 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: 04/28/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596404212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/02/2021; 04/20/2021
• Supplement Dates FDA Received: 03/03/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention