MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FIBULAR PLATE LEFT 6 HOLES 106 MM LENGTH; PLATE, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Discharge (2225); Osteolysis (2377)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - the event occurred in (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.

Event Description

It was reported that during a routine removal of the fracture plate a discharge was noted as being caused from osteolysis.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed due to visual inspection.Visual inspection of the returned plate noted discoloration/ debris in one of the screw holes.The product was sent to sem for further evaluation.Eds semi-quantitative elemental analysis of the discoloration indications on the plate revealed c, n, o, na, mg, p, cl, k, and ca as the major foreign elements.The source of these elements could be from various potential contaminants including biological soft tissue and bone, dried biological fluids (i.E.Blood), bone cement (calcium phosphate-based), corrosion/metal oxide product or various decontamination solutions (i.E.Hospital detergents).Therefore, the source of these elements is inconclusive.It is inconclusive whether the discoloration indications on the plate is a result of corrosion products, biological, or environmental contamination.The eds analysis of the discoloration free area on the fibular plate sample showed that the elements identified in the spectra were consistent with 22-13-5 stainless steel grade.- review of dhr noted the product was manufactured conforming to specifications.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: DISTAL LATERAL FIBULAR PLATE LEFT 6 HOLES 106 MM LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7436904
• MDR Text Key: 105694322
• Report Number: 0001822565-2018-01768
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK070906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00235701806
• Device Lot Number: 63337290
• Other Device ID Number: (01) 00889024055919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 03/06/2019
• 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
• Patient Weight: 46