MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZPLP FIBULAR PLATE; PLATE, FIXATION

Catalog Number UNKNOWN

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Citation : park, sung j., et al."metallosis after using distal fibular locking plate for lateral malleolar fractures: a retrospective study." orthopaedic surgery, 1 mar.2021, pp.1-7, doi:https://doi.Org/10.1007/s00402-020-03713-y.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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 as the necessary information to adequately investigate the reported event was not provided.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.Product not returned.

Event Description

The study reported 4 patients noted to have metallosis at the locking hole upon hardware removal; one of which was a (b)(6) year old female who received a 6 hole plate for a right trimalleolar fracture.A journal article was retrieved from archives of orthopaedic and trauma surgery (2021) that reported a retrospective study from the republic of korea that looked at the development of metallosis following orif of fractures.The purpose of the study was to assess metallosis following orif using distal fibular locking plates to treat distal fibular fractures.The study reviewed 69 patients who underwent surgery using locking compression plates to treat lateral malleolar fractures with subsequent hardware removal; of these patients, 38 received a zplp plate (zimmer biomet), 16 received synthes lcp plates, and 15 received je-il arix plates.The surgeries were performed at inha university hospital (korea).Of the zplp recipients, 19 patients had unimalleolar fractures, 7 had bimalleolar fractures, and 12 had trimalleolar fractures; 2 patients were classified as weber type a, 31 were weber type b, and 5 were weber type c.The study population had a mean age of 49.3 years at time of surgery (range 18-70 years).Follow-up was conducted at approximately 4-5 times within the first year postoperatively with a mean length of follow-up for 13.92 months (range 12-31 months).

• Brand Name: UNKNOWN ZPLP FIBULAR PLATE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11948216
• MDR Text Key: 254857002
• Report Number: 0001822565-2021-01543
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR