MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO TC CAPITATESTEM 6X12MM; PROSTHESIS, WRIST

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Burning Sensation (2146); Tingling (2171)

Event Date 09/26/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 180181, maestro radial stem, 172020, 180151, maestro rad w/brg 7x15 7.5 rt, 002440, 180350, variable lock screw 4.75x15mm, 551350, 180354, variable lock screw 4.75x35mm, 551310, 180363, maestro tc carpalhd 7x15mm std, 457600, 180395, maestro tc carpal plate 9x37mm, 605040.Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 09572.

Event Description

It was reported by the patient¿s legal counsel that the patient underwent wrist arthroplasty.Subsequently, it is alleged that the patient is experiencing tingling, burning, and pain in her fingers, a painful lump in her wrist, and loosening.No revision procedure has been reported to date.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

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.

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.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is 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.

Event Description

It was reported by the patient¿s legal counsel that the patient underwent wrist arthroplasty.Subsequently, it is alleged that the patient is experiencing tingling, burning, and pain in her fingers, a painful lump in her wrist, loosening, as well as nerve/ tendon irritation from the prosthesis being too large for the patient.No revision procedure has been reported to date.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products- cobalt hv bone cement 40g, catalogue# 402282, lot# 979340 received and reviewed primary surgical operative notes.The preop/postop diagnosis was right wrist osteoarthritis and right wrist scapholunate advanced collapse.The procedure included a right arthroplasty, proximal row carpectomy and posterior interosseous nerve neurectomy.With regards to sizing, the surgeon trialed the capitate plate with a 6mm augment which was too large.The surgeon then went to the smallest carpal head which seemed to fit well; however, he did have to trim the captitate head with an oscillating saw as well as remove a small portion of the trapezoid in order to have the plate fit flush.On the radial side, the surgeon reamed for a 26mm.The trial implant was placed and found to be proud.The surgeon recut approximately 3mm more in order to seat the trial.All trials were then placed and found to reproduce anatomy well allowing approximately 2mm of distraction.The final implants were placed and found to be satisfactory.No complications were noted during the procedure per the surgeon.Root cause remains undetermined.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: MAESTRO TC CAPITATESTEM 6X12MM
• 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: 6969740
• MDR Text Key: 89998440
• Report Number: 0001825034-2017-09573
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/29/2023
• Device Model Number: N/A
• Device Catalogue Number: 180320
• Device Lot Number: 091780
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2013
• 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; Other
• Patient Age: 63 YR
• Patient Weight: 94