MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COONRAD-MORREY TOTAL ELBOW; PROSTHESIS, ELBOW, CONSTRAINED

Catalog Number	32810502704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Adhesion(s) (1695); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Numbness (2415); Peripheral Nervous Injury (4414)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# unk ulnar component; lot# unknown.Item# unk bushing; lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 or Problem Description
It was reported that the patient underwent a resection of heterotopic bone and an ulnar nerve transposition due to numbness and tingling of the ulnar digits approximately six (6) months post-implantation.All original implants were retained during the procedure.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
The following sections were updated/corrected: b4; b5; b7; d2; d10; g1; g3; g4; g6; h1; h2; h6; h10.D10: item# 32810504301; lot# 64662236.Item# 110034355; lot# 918aak1906.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a resection of heterotopic bone and an ulnar nerve transposition due to numbness and tingling of the ulnar digits approximately six (6) months post-implantation.Subsequently, the patient underwent a second ulnar nerve transposition approximately eight (8) months later.Both procedures were completed without complication and all original implants remain in place.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; b7; d2; g1; g3; g6; h1; h2; h6.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.H6: proposed component code: mechanical (g04): stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.I&d op note: this is a 71-year-old woman with a history of left total elbow arthroplasty for severely comminuted distal humerus fracture.She initially did reasonably well, then had some numbness and tingling of the ulnar digits and had a transposition of the ulnar nerve resection of left elbow joint: lateral condyle of distal humerus, neurolysis of ulnar nerve, radical resection of capsule, soft tissue & heterotopic bone with contracture release".Office note: during the surgery two weeks ago, had lysis of adhesions around the nerve.Office note: pain/rom better than what it was prior to surgery, slowly improving.Rom 30-115, tingling and numbness into fingers persistently.Continue physical therapy.Office visit: feels like hit a plateau in therapy, improved flexion.Has cervical spine surgery coming up to deal with numbness and tingling into fingers.Ordered dyna-splint.Will order emg/ncs to evaluate areas of compression of the ulnar nerve.Office note: continues to have numbness and tingling into the ulnar digits primarily, though she does have some difficulty using the radial fingers as well.Difficulty buttoning objects like a shirt.She has noted some atrophy in the hand.This is all begun since her elbow replacement for severe distal humerus fx.Ncs: compression on the nerve study at the elbow as well as at the wrist on the ulnar nerve, and there is minor carpal tunnel syndrome- compression of the ulnar nerve at multiple levels.Office note: operative clearance by cardiology.Transposition of ulnar nerve: dx: compression of ulnar nerve at multiple levels.Procedure: decompression of ulnar nerve ¿ nerve transposition at elbow, left carpal tunnel release, repair ulnar nerve.Office note: 2 weeks post-operation of transposition of ulnar nerve, release of guyon's canal and release of carpal.Tunnel on left.Healing well, physical therapy.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Heterotopic ossification (ho) is the abnormal and rapid growth of bone that forms within soft tissue as the result of heredity, trauma, surgical history, or diseases of a joint.Ho may be a contributing factor to the pain and range of motion; however, for pain, rom, and nerve damage, a definitive root cause cannot be determined.The reported event is confirmed as medical records were provided.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COONRAD-MORREY TOTAL ELBOW
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21366018
• Report Number: 0001822565-2025-00344
• Device Sequence Number: 20936660
• Product Code: JDC
• UDI-Device Identifier: 00889024274006
• UDI-Public: (01)00889024274006(17)250131(10)64449972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 32810502704
• Device Lot Number: 64449972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/06/2025; 02/25/2025; 07/07/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/20/2025; 03/18/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG