MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 150 MM LENGTH LONG FLANGE; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	01/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: 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.
Event or Problem Description
It was reported there was a revision for removal of a total elbow prosthesis due to an unknown product defect.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Proposed annex g code: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Event or Problem Description
It was further reported that the patient had an initial right elbow arthroplasty approximately 4 years ago.Subsequently, the patient had a revision about a year ago due to rupture of humeral stem found on x-rays taken approximately 8 months prior.The prosthesis was replaced, and allograft was used in the reconstruction.No further details or outcomes have been provided.
Additional Manufacturer Narrative
(b)(4).D6a - 2019.D10 - medical product: catalog #: 00840019501, bearing-a-sz5/6, lot # 64076417.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as visual examination of the returned product/provided pictures identified the stem is fractured.Damage is seen near the fracture.The plasma spray is smeared/damaged.An unknown ulnar is still assembled to the humeral with bearings, axle pin, and humeral screws.Sem analysis of the returned product identified the following: the fracture surface appears quite complex with significant post-fracture damage/smearing.Sem imaging found ductile dimples as well as possible fatigue striations.Fracture surface artifacts suggest a possible fatigue fracture coupled with torsional overload.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 150 MM LENGTH LONG FLANGE
• 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: 16808862
• Report Number: 0001822565-2023-01095
• Device Sequence Number: 17668669
• Product Code: JDC
• UDI-Device Identifier: 00889024271401
• UDI-Public: (01)00889024271401(17)260430(10)63306627
• 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 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,Followup
• Report Date (Section B): 05/29/2024

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 Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00840005515
• Device Lot Number: 63306627
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 12/08/2023; 05/23/2024
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 09/01/2023; 12/29/2023; 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 75 KG