MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED SIZE 5 75 MM LENGTH LEFT FOR CEMENTED USE ONLY; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	00840001507
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial implantation approximately three (3) years ago as part of a clinical study.Subsequently, patient had fallen and suffered a peri-prosthetic fracture near the humeral component.Patient was not revised and was being treated conservatively with a splint.At the two (2) year follow up, the site reported loosening of the humeral component at the site of the peri-prosthetic fracture.Examination of x-rays also noted loosening of ulnar component.Currently, the site notes this as mild and tolerated with no current plan for revision.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Item# 00840004510; lot# 63691823, item# 00840009500; lot# 63930799.Full establishment name : (b)(6).Foreign: (b)(6) 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6-component code recommendation mechanical (g04) - stem.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6.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: two views of the left elbow demonstrate a left total elbow arthroplasty with loosening of the proximal ulnar component.Mild radiolucency along the bone cement interface of the distal humeral component could indicate loosening as well.No bony fracture seen.Radial head resection.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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: ULNAR COMPONENT PLASMA SPRAYED SIZE 5 75 MM LENGTH LEFT FOR CEMENTED USE ONLY
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: 14324628
• Report Number: 0001822565-2022-01346
• Device Sequence Number: 4891216
• Product Code: JDC
• UDI-Device Identifier: 00889024271241
• UDI-Public: (01)00889024271241(17)270831(10)63670155
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: 00840001507
• Device Lot Number: 63670155
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• 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 NARRAITVE IN H10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 58 KG