MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO RAD W/BRG 7X15 7.5 LT; PROSTHESIS, ELBOW

Catalog Number 180150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Synovitis (2094); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Date 06/19/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 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.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.

Event Description

It was reported that the patient underwent a left wrist arthroplasty.Subsequently, the patient was experiencing sharp pains and limited range of motion (rom), leading to medication, physical therapy, and monthly doctor visits for approximately 2 years post op.Nearly 3 years after initial surgery, a left wrist extensive extensor tendon tenolysis, extensor carpri radialis longus transfer, and repair of extensor digitorum was performed.Patient is still experiencing similar pain and rom issues.Implants remain implanted.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.

Manufacturer Narrative

D11: maestro tc carpalpt 9x37 12 ag cat# 180305 lot# 466030.Variable lock screw 4.75x40mm cat# 180355 lot# 438580.Variable lock screw 4.75x15mm cat# 180350 lot# 438530.Cobalt mv bone cement 40gm b cat# 402439 lot# 589540.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04061, 0001825034 - 2020 - 04062, 0001825034 - 2020 - 04063, 0001825034 - 2020 - 04064.

Event Description

Additional information received indicates the patient was also experiencing weakness and loss of extension in the wrist due to rheumatoid arthritis, flexion contracture, and tendon tear resulting in additional surgical intervention with 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient reports limited function and pain since surgery (4 weeks postop).Patient continues to demonstrate limited passive and active wrist extension, she was able to demonstrate 5° of extension with place and hold.Pt still demonstrates 0° of wrist flexion in the prefab splint.Her splint was padded to improve her wrist extension.(b)(6) 2015 - patient reports moderate pain and weakness in the left hand, limited rom in the left wrist, has been using a brace and doing pt.Dynamic splinting recommended and wrist control brace to stabilize the wrist, apply ice as needed, nsaids, wbat, possible plan for contracture release.(b)(6) 2016 - patient reports mild pain and weakness in the left hand, limited rom in the left wrist with worsening rom, pt completed, continues hep, wears wrist brace at night, uses dynamic splint.¿there is no active extension of the fingers or wrist,¿ passive rom 5°.Diagnoses: contracture, extensor tendon rupture.Advised patient there may be some benefit from reconstruction of the wrist and/or finger extensor tendons with tendon transfers and staged left wrist contracture release.(b)(6) 2017, patient received 1.Left wrist extensive extensor tendon tenolyis, 2.Extensor carpi radialis longus transfer to extensor carpi radialis brevis, 3.Repair of extensor digitorum communis to all digits using tendon graft, 4.Manipulation of left wrist under anesthesia.Dx: left wrist spontaneous rupture of multiple extensor tendons status post prior total wrist arthroplasty, left wrist contracture, moderate to severe rheumatoid arthritis.During surgery, the following findings were noted: 1.Left wrist flexion contracture with complete rupture of all tendons of the extensor digitorum communis as well as the extensor carpi radialis brevis tendons.The extensor pollicis longus tendon is intact and the extensor carpi radialis longus tendon is intact but subluxed volarly.2.Moderate to severe scarring around the site of previous surgery.3.Total wrist arthroplasty with joint in reasonably good position.4.Relatively unstable druj (distal radial ulnar joint).Surgeon informs patient that multiple surgeries may be required and ongoing pain and complications are likely due to ra.¿upon opening the extensor retinaculum, the significant underlying synovitis was encountered.¿ ¿the hardware appeared to be intact and in good position.The wrist contracture resulted in a slightly proud hardware over the dorsum of the wrist and was likely contributed to the rupture of the overlying extensor tendons.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: MAESTRO RAD W/BRG 7X15 7.5 LT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10635837
• MDR Text Key: 210210537
• Report Number: 0001825034-2020-03693
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• PMA/PMN Number: K042032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 180150
• Device Lot Number: 265820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 51