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

Catalog Number	00235700908
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: DISTAL LATERAL TIBIAL PLATE RIGHT 8 HOLES 118 MM LENGTH
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10123059
• Report Number: 0001822565-2020-02003
• Device Sequence Number: 16856540
• Product Code: HRS
• UDI-Device Identifier: 00889024055773
• UDI-Public: (01)00889024055773
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/15/2020; 10/26/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 06/17/2020; 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SCREW; UNK SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Weight: 65