MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT; PROSTHESIS, ELBOW

Model Number	00-8400-014-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part: 00840009400 lot: unknown articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product do not resterilize part: 00840009000 lot: unknown humeral screw kit 2 humeral screws.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01895.
Event or Problem Description
It was reported that the patient underwent initial elbow surgery.Subsequently, the patient was revised approximately seven years post initial procedure due to early aseptic loosening.No additional patient consequences were reported.
Event or Problem Description
No additional event information is 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: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Proposed component code: mechanical (g04) - stem.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of radiographs.Visual examination of the returned nexel ulnar stem identified bone cement is covering the plasma spray and etch detail ¿ the manufacturing lot cannot be determined.Review of the available records identified the following: periprosthetic zone of lucency noted surrounding the hardware in the ulna on the frontal and lateral views.The lateral view demonstrates anterior migration of the distal tip of the ulnar hardware component which extends to contact and possibly breech the anterior cortex of the proximal ulna diaphysis.No periprosthetic lucencies are confirmed in the humeral component, although the proximal tip of the hardware is closely approximated with the dorsal cortex.Slight eccentric positioning of the humeral component (dorsal) is age indeterminate and could be related to initial surgical technique.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT
• Common Device Name: PROSTHESIS, ELBOW
• 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: 14852732
• Report Number: 0001822565-2022-01893
• Device Sequence Number: 4743739
• Product Code: JDC
• UDI-Device Identifier: 00889024271227
• UDI-Public: (01)00889024271227
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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 Model Number: 00-8400-014-07
• Device Catalogue Number: 00840001407
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 59 KG