MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VARIABLE LOCK SCREW 4.75X40MM; PROSTHESIS, WRIST

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 180322, maestro tc capitatestem 6x18mm, 013330, 180363, maestro tc carpalhd 7x15mm std, 818610, 180482, maestro radial stem 7.5x60mm, 738690, 180151, maestro rad w/brg 7x15 7.5 rt, 217150, 180351, variable lock screw 4.75x20mm, 551340, 180352, variable lock screw 4.75x25mm, 551330, 180304, maestro tc carpalpt 9x37 9 aug, 837790, 180357, variable lock screw 4.75x50mm, 872250.Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04268, 0001825034 - 2018 - 04269, 0001825034 - 2018 - 04270, 0001825034 - 2018 - 04271, 0001825034 - 2018 - 04272, 0001825034 - 2018 - 04273, 0001825034 - 2018 - 04266, 0001825034 - 2018 - 04275.Product location unknown.

Event Description

It was reported that the patient¿s original wrist replacement had to be removed due to infection and caused the carpals to be damaged enough that a standard plate would not work.Subsequently, the surgeon requested a patient matched carpal plate to get a new wrist replacement.In addition, the surgeon believes the risk of infection coming back to the pointer finger requires custom screw placement.No further information has been provided.

• Brand Name: VARIABLE LOCK SCREW 4.75X40MM
• Type of Device: PROSTHESIS, WRIST
• 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: 7638024
• MDR Text Key: 112335668
• Report Number: 0001825034-2018-04274
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 180355
• Device Lot Number: 551300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention