MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXTRA SMALL RIGHT 3 INCH LENGTH CEMENTED INTERCHANGEABLE ULNAR ASSEMBLY; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 32810502704, interchangeable humeral assembly, lot # 65012733.G2: france.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01387.H3 other text : unknown.
Event or Problem Description
It was reported that the patient had an initial surgery approximately 2 years ago.Subsequently, the patient is experiencing pain secondary to a possible cobalt chrome allergy.A future revision procedure is indicated; however, no revision procedure has been reported to date.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).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 further reported that the revision took place approximately a month ago.
Additional Manufacturer Narrative
(b)(4).Proposed g-code: mechanical (g04) - stem updated: b4, b5, d2, g4, h1, h2, h3, h6, h10 the reported event is not confirmed as as the implants do not contain cobalt chromium and the source for the pain is unknown.Radiographs were reviewed and if was found that the elbow arthroplasty alignment is anatomic.There is no fracture.Radiolucency is noted along the humeral implant which may be loose but is not displaced.Bone quality is markedly osteopenic.Two months later it was seen that the elbow arthroplasty alignment is anatomic.There is no fracture.Bone quality is again markedly osteopenic.There is slight interval progression of the osteolysis along the humeral implant without displacement.The over all impressions show radiolucency along the humeral implant consistent with osteolysis, and with possible implant loosening as noted and subsequent pain.Implant alignment is maintained.Bone quality is markedly osteopenic.Device history record was reviewed and no discrepancies relevant to the reported event were found.Allergy: upon conclusion of the investigation, no problem was found with the given devices as the implants do not contain cobalt chromium.Pain: 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: EXTRA SMALL RIGHT 3 INCH LENGTH CEMENTED INTERCHANGEABLE ULNAR ASSEMBLY
• Common Device Name: EXTREMITY IMPLANT
• 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: 16984818
• Report Number: 0001822565-2023-01385
• Device Sequence Number: 6693590
• Product Code: JDC
• UDI-Device Identifier: 00889024274105
• UDI-Public: (01)00889024274105(17)260902(10)65087288
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 11/30/2023

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: 09/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 32810504302
• Device Lot Number: 65087288
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 06/26/2023; 11/20/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/21/2023; 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 73 KG