MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR VOLAR RIM L ST; ORTHOPAEDIC FIXATION PLATE

Catalog Number 131824051

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Osteopenia/ Osteoporosis (2651)

Event Date 09/01/2017

Event Type  Injury  

Event Description

It was reported that a patient of a retrospective study on dvr plates was revised approximately nine (9) months post-implantation due to experiencing stiffness of the wrist and irritation caused by the plate.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Full establishment name - (b)(6).Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 a patient of a retrospective study on dvr plates was revised approximately eight (8) months post-implantation due to experiencing stiffness of the wrist and irritation caused by the plate.Subsequently, it was later reported that the plate was malpositioned upon implantation.It was stated that the plate was applied too volar and not snugged down to the bone so it irritated the tendons.It was a volar rim plate too so the flanges were irritating the fpl tendon.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records; lot identification was not provided.It is alleged that the plate was applied too volar and not snugged down to the bone so it irritated the tendons; however without medical records this cannot be confirmed.Therefore, a definitive root cause cannot be identified.If any further information 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.

• Brand Name: DVR VOLAR RIM L ST
• Type of Device: ORTHOPAEDIC FIXATION PLATE
• 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: 13367732
• MDR Text Key: 284535078
• Report Number: 0001825034-2022-00211
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 131824051
• Device Lot 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: 03/25/2022
• 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
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female