MAUDE Adverse Event Report: BIOMET TRAUMA DVR CROSSLOCK LOCK MEDIUM L; APPLIANCE, FIXATION

Model Number N/A

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event - unknown date approximately one (1) week prior to revision, and approximately one (1) week after primary procedure.Implant date - unknown date approximately one (1) week prior to revision.Concomitant medical product:- non locking screw catalog#: 131227216 lot#: unk, non locking screw catalog#: 131227214 lot#: unk, smooth locking peg catalog#: 131227018 lot#: unk, smooth locking peg catalog#: 131227016 lot#: unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06132, 0001825034-2017-06134, 0001825034-2017-06137, 0001825034-2017-06136.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the surgeon has retained the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient initially underwent an open reduction internal fixation left wrist procedure.Approximately one (1) week post op the patient reported extreme pain.Patient underwent a revision procedure approximately one (1) week after the onset of pain.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 is reported that the patient initially underwent an open reduction internal fixation left wrist procedure.Approximately one (1) week post op the patient complained of extreme pain.Subsequently, two (2) weeks post op the patient underwent a revision surgery to replace all products, as the surgeon determined that the initial placement of the products was not ideal.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Exact initial and revision surgery dates are unknown.However, it is known that the revision surgery occurred two (2) weeks post op of the initial procedure.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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.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.

• Brand Name: DVR CROSSLOCK LOCK MEDIUM L
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6784048
• MDR Text Key: 82467398
• Report Number: 0001825034-2017-06131
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2018

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: 131822060
• Device Lot Number: SBMO68387
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/10/2017
• Supplement Dates Manufacturer Received: 08/08/2017; 08/22/2017; 01/03/2018
• Supplement Dates FDA Received: 08/21/2017; 08/31/2017; 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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