MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL TIBIAL PLATE RIGHT 8 HOLES 118 MM LENGTH; PROSTHESIS, TRAUMA

Catalog Number 00235700908

Device Problem Material Discolored (1170)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Full hospital name - (b)(6) hospital.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital did not approve for its return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that the patient was implanted approximately one (1) year ago with distal lateral tibial plate.One (1) year post-implantation, it was time to have plate removed per surgeon.Surgeon noticed plate had blackened residue on it.No blackened residue was noted on the screw rod.Doctor washed out black residue and removed corresponding soft tissue.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d4; e1; g4; g7; h1; h2 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 submitted to relay additional information.No product was returned, dimensional evaluations could not be performed.Pictures were provided for the plate, visual inspection noted black discoloration on the screw hole.Insufficient information provided.Unable to perform a compatibility check.Medical records were not provided.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: DISTAL LATERAL TIBIAL PLATE RIGHT 8 HOLES 118 MM LENGTH
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10123059
• MDR Text Key: 194130148
• Report Number: 0001822565-2020-02003
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024055773
• UDI-Public: (01)00889024055773
• Combination Product (y/n): N
• PMA/PMN Number: K050121
• 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: 10/27/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00235700908
• Device Lot Number: 64010779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/15/2020; 10/26/2020
• Supplement Dates FDA Received: 06/17/2020; 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: UNK SCREW; UNK SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 65