MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RADIAL STEM; PROSTHESIS, WRIST

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Swelling (2091)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: part # unk, radial body, lot # unk.Part # unk, carpal plate, lot # unk.Part # unk, capitate stem, lot # unk.Part # unk, carpal head, lot # unk.Part # unk, radial screw, lot # unk.Part # unk, ulnar screw, lot # unk.Event occurred in (b)(6).Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-11304, 0001825034-2018-11305, 0001825034-2018-11307, 0001825034-2018-11308, 0001825034-2018-11309, 0001825034-2018-11310.

Event Description

It was reported that approximately 8 years post implantation, the patient had reports of swelling and pain to the wrist.During the first-stage revision, the surgeon had discovered loosening, migration and fracturing of the screws, and local "metalosis".Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of x-rays and photographs.The porous part of the radial stem showed some bone growth.The radial body is worn possibly due to loosened carpal head.Damage on back of radial body possibly happened during explantation.X-rays reviewed showed suggestion of loosening of the radial component and eventual subsidence of the carpal component.Backing out of the ulnar screw also seen as a result.Device history records could not be reviewed as lot number is unknown.A definite root cause cannot be determined with the information 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.

Event Description

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

• Brand Name: RADIAL STEM
• Type of Device: PROSTHESIS, WRIST
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8184142
• MDR Text Key: 130994358
• Report Number: 0001825034-2018-11306
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention