MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 32810506302, interchangeable ulnar assembly, lot # 63694916.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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.Product will not be returned.
Event or Problem Description
It was reported the patient underwent an initial right shoulder anthroplasty subsequently, the patient was revised to disassociation of the pin seen on x-ray approximately five (5) months post implantation.No additional information is available 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 patient sustained a fall resulting in a fracture of right proximal humerus and right distal humerus.Approximately six (6) months ago.The right elbow arthroplasty & right total reverse shoulder were performed.Subsequently about 3 months ago underwent revision procedure of right elbow due to pin backed out.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was considered confirmed as the medical records stated that the locking pin had backed out.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: INTERCHANGEABLE HUMERAL ASSEMBLY
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9481432
• Report Number: 0001822565-2019-05321
• Device Sequence Number: 16490037
• Product Code: JDC
• UDI-Device Identifier: 00889024274044
• UDI-Public: (01)00889024274044
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 32810503506
• Device Lot Number: 63151665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 04/10/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/13/2020; 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Weight: 86