MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED; PROSTHESIS, EXTREMITIES

Catalog Number	00840001407
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 00840004410; lot# 63989902, item# 00840009000; lot# 64093871, item# 00840009400; lot# 64083061.Report source: foreign - event occurred in (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a hinge-type elbow arthroplasty is present and alignment is anatomic.There is no fracture.There is extensive lucency along the elbow implant extending through the stem and the implant appears radiographically loose.There is faint lucency along the distal aspect of the humeral implant but no lucency along the humeral stem.Osseous proliferation is noted at the distal humerus and proximal ulna and may be associated with impingement.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.A contributing factor to the loosening is the impingement, however, it could not be confirmed whether the bone growth happened over time or inadequate bone was removed in the initial surgery as op notes and radiographs directly post-op of the initial surgery were 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 or Problem Description
It was reported that a patient was revised approximately three (3) months post-implantation due to loosening caused by a bony impingement as a result of the original surgery technique.Attempts have been made and no further information has been provided.

• Brand Name: ULNAR COMPONENT PLASMA SPRAYED
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12239619
• Report Number: 0001822565-2021-02113
• Device Sequence Number: 4848187
• Product Code: JDC
• UDI-Device Identifier: 00889024271227
• UDI-Public: (01)00889024271227(17)280930(10)64017606
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00840001407
• Device Lot Number: 64017606
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR