MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS IC SEG - 30MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00914.Medical products: item#: unknown, unknown distal body; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 underwent a l.Shoulder arthroplasty on an unknown date.Subsequently the patient was revised on an unknown date due to the taper disassociating with the distal body.
Event or Problem Description
It was reported that the patient was revised due to implants disassociated.The implants were explanted during revision and then re-implanted after they were tightened and it was determined they would not disassociate.No operative notes are available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00914-1.D10: medical product: item#: 110029824, comp srs nexel 50mm dst bdy lt; lot#: 423350.Item#: 110029824, comp srs nexel 50mm dst bdy lt; lot#: 423350.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional/corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00914-2.Visual examination of the provided pictures identified the products connected in the joint space.However, as the products were not returned, further analysis could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the left elbow demonstrate a left total elbow arthroplasty with separation of the stem from the distal component.Hetero topic ossification within the joint space.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
It was reported that the patient underwent an initial left elbow surgery approximately two (2) years and seven (7) months ago.Subsequently, the patient needed a second surgery as the implants disassociated.The surgeon was able to reconnect and checked for tightness of the implants while the implants remained in the patient and never left the sterile field.

• Brand Name: COMPR SRS IC SEG - 30MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14118250
• Report Number: 0001825034-2022-00913
• Device Sequence Number: 4314274
• Product Code: JDC
• UDI-Device Identifier: 00880304507784
• UDI-Public: (01)00880304507784(17)311006(10)623000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 10/31/2022
• 2 Devices were Involved in the Event: 1 2

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: N/A
• Device Catalogue Number: 211224
• Device Lot Number: 623000
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 04/19/2022; 10/31/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 04/28/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female