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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO TC CAPITATESTEM 6X18MM TOTAL WRIST CARPUS PROSTHESIS

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ZIMMER BIOMET, INC. MAESTRO TC CAPITATESTEM 6X18MM TOTAL WRIST CARPUS PROSTHESIS Back to Search Results
Catalog Number 180322
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 09/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: maestro tc carpalhd 7x15mm std cat# 180363 lot# 452120; unk radial body cat#ni lot#ni; unk radial stem cat#ni lot#ni; maestro tc carpalpt 9x43 8 aug cat# 180306 lot# 380980; variable lock screw 4. 75x50mm cat# 180357 lot# 559140. Visual examination of the provided pictures identified that the devices were explanted and confirmed part and lot numbers for the carpal component. No definitive statements can be made about the condition of the products as it is unknown whether the damage occurred intraoperatively or during explanting. Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event. Radiographs were provided and reviewed by a health care professional. Review of the available records identified the following: three views of the right wrist demonstrate a wrist arthroplasty with loosening of both the radial and carpal components, also with dislocation of the arthroplasty. Distal ulnar resection. Osteopenia is present with bony fragmentation noted. Erosion versus screw tract involving the base of the fifth metacarpal. Radiocarpal arthroplasty dislocation with loosening of both the radial and carpal components. A definitive root cause cannot be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02773, 0001825034-2021-02776, 0001825034-2021-02774, 0001825034-2022-00078 and 0001825034-2022-00077.
 
Event Description
It was reported patient underwent a revision procedure due to aseptic loosening. Attempts to obtain additional information have been made; however, no more is available at this time.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: maestro tc carpalhd 7x15mm std cat# 180363 lot# 452120; unk radial body cat#ni lot#ni; unk radial stem cat#ni lot#ni; maestro tc carpalpt 9x43 8 aug cat# 180306 lot# 380980; variable lock screw 4. 75x50mm cat# 180357 lot# 559140. Visual examination of the provided pictures identified that the devices were explanted and confirmed part and lot numbers for the carpal component. No definitive statements can be made about the condition of the products as it is unknown whether the damage occurred intraoperatively or during explanting. Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event. Radiographs were provided and reviewed by a health care professional. Review of the available records identified the following: three views of the right wrist demonstrate a wrist arthroplasty with loosening of both the radial and carpal components, also with dislocation of the arthroplasty. Distal ulnar resection. Osteopenia is present with bony fragmentation noted. Erosion versus screw tract involving the base of the fifth metacarpal. Radiocarpal arthroplasty dislocation with loosening of both the radial and carpal components. A definitive root cause cannot be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02773, 0001825034-2021-02776, 0001825034-2021-02774, 0001825034-2022-00078 and 0001825034-2022-00077.
 
Event Description
It was reported patient underwent a revision procedure due to aseptic loosening. Attempts to obtain additional information have been made; however, no more is available at this time.
 
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Brand NameMAESTRO TC CAPITATESTEM 6X18MM
Type of DeviceTOTAL WRIST CARPUS PROSTHESIS
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 Key13311194
MDR Text Key285432427
Report Number0001825034-2022-00079
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 Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number180322
Device Lot Number427590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/20/2022 Patient Sequence Number: 1
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