MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES

Model Number	32-8105-25-04
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01884.Concomitant medical products: item#: 32810504302, pt hybrid glen post regenerex; lot#: 964350, item#: 32810502501, c/m pin/bushing rev kit, small/regular humerus; lot#: 64584581, item#: 00888700200, bactisure wound lavage ww, lot#: q2105392.Customer has indicated that the product will not be returned to zimmer biomet for investigation as product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had an initial right total elbow eleven (11) years and three (3) months and had started to experience pain, swelling, and a squeaking noise.Subsequently, the patient underwent a right elbow revision surgery due to implant failure due to implant wear and metallosis.During the procedure, the surgeon noted chronic changes, scar tissue and heterotopic bone.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component codes: mechanical (g04) - stem no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right elbow arthroplasty implants are present without fracture or dislocation.There is mild angulation of the humeral and ulnar alignment on the ap view without frank malalignment.There is no evidence of implant loosening or other abnormality.The implant fit is maintained.Bone quality is osteopenic.There is regional soft tissue swelling and a small amount of anterior joint line heterotopic ossification.Timeline reviews were provided and reviewed identifying the following: (b)(6), 2022 office visit -- symptoms persisted despite ot for strengthening-current pain level 7/10.The patient complained of constant radiating pain (to forearm) with activities and at night.The patient was taking opioid pain medication.Swelling was present, and the patient noted squeaking of the joint with rom.3 x-rays were completed: retained suture anchor in the lateral column of the distal humerus; chronic changes were noted but no apparent loosening of the ulnar or humeral components; appearance of asymmetric wear of the polyethylene; and potential metal-on-metal contact.Revision surgery to revise the bushing and polyethylene recommended, ulnar and humeral components were felt to be stable.(b)(6), 2022 revision surgery -- general anesthesia with regional block, ebl 25ml.Significant scar tissue was encountered and carefully resected.Heterotopic bone was removed about the elbow joint.The humeral and ulnar components were not loose, they demonstrated secure fixation.Significant damage to the polyethylene, at least one area was completely eroded.Metallosis was noted about the joint and was carefully debrided.New components were placed without issue.Zimmer biomet bactisure wound lavage was utilized.The elbow had full rom at completion of the procedure.No intra-op complications were noted.The patient was transferred to pacu in stable condition and discharged home the same day.Plan: routine follow-up in about 2 weeks post-op.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: INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES
• 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: 15275801
• Report Number: 0001822565-2022-02435
• Device Sequence Number: 15192559
• Product Code: JDC
• UDI-Device Identifier: 00889024508590
• UDI-Public: (01)00889024508590(17)160331(10)61635055
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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 Expiration Date: 03/31/2016
• Device Model Number: 32-8105-25-04
• Device Catalogue Number: 32810502504
• Device Lot Number: 61635055
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2011
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG