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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VARIABLE LOCK SCREW 4.75X15MM ORTHOPAEDIC BONE PIN

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ZIMMER BIOMET, INC. VARIABLE LOCK SCREW 4.75X15MM ORTHOPAEDIC BONE PIN Back to Search Results
Catalog Number 180350
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Synovitis (2094); Tissue Damage (2104); Patient Problem/Medical Problem (2688)
Event Date 06/19/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: maestro radial stem 6. 0x40mm cat# 180181 lot# 172020. Maestro tc carpalhd 7x15mm std cat# 180363 lot# 706680. Maestro tc capitatestem 6x15mm cat# 180321 lot# 827400. Maestro rad w/brg 7x15 7. 5 lt cat# 180150 lot# 265820. Maestro tc carpalpt 9x37 12 ag cat# 180305 lot# 466030. Variable lock screw 4. 75x40mm cat# 180355 lot# 438580. Cobalt mv bone cement 40gm b cat# 402439 lot# 589540. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03690. 0001825034 - 2020 - 03691. 0001825034 - 2020 - 03692. 0001825034 - 2020 - 03693. 0001825034 - 2020 - 04061. 0001825034 - 2020 - 04062. 0001825034 - 2020 - 04064.
 
Event Description
It was reported that the patient underwent a left wrist arthroplasty. Subsequently, the patient was experiencing sharp pains, weakness and limited range of motion (rom), leading to medication, physical therapy, and monthly doctor visits for approximately 2 years post op. Further, the patient experienced loss of extension in the wrist due to rheumatoid arthritis, flexion contracture, and tendon tear. Nearly 3 years after initial surgery, a left wrist extensive extensor tendon tenolysis, extensor carpri radialis longus transfer, repair of extensor digitorum was performed, and manipulation of left wrist. The soft tissue correction procedure was completed without complication. The surgeon noted the patient had a complete rupture of all tendons of the extensor digitorum communias as well as the extensor carpi radialis brevis tendons. Further, the patient had severe scarring around the site of the previous surgery. All hardware was intact, in proper position, and left in place. Since the procedure, the patient has reported ongoing pain and limited range of motion. A revision procedure is indicated as necessary; however, no revision procedure has been reported to date. Attempts have been made and additional information is unavailable at the time of this report.
 
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Brand NameVARIABLE LOCK SCREW 4.75X15MM
Type of DeviceORTHOPAEDIC BONE PIN
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 Key10822326
MDR Text Key215942693
Report Number0001825034-2020-04063
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number180350
Device Lot Number438530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 11/11/2020 Patient Sequence Number: 1
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