MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X40MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	115398
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a two stage revision arthroplasty of the left shoulder prosthesis approximately sixteen (16) months post revision arthroplasty due to infection, which caused the loosening of the implant and led bone loss of the glenoid.Due to this, the implant fractured.The physician feels that the infection started after the initial surgery and that it has remained until this two stage revision when the infection was treated.
Additional Manufacturer Narrative
(b)(4).The event was initially reported on 001825034-2022-01511; however, needed to be corrected and will now be reported on this mfr multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01510-1, 0001825034-2022-01512-1, 0001825034-2022-01515-1.Concomitant medical products: item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 044810.Item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 453060.Item#: 180550, comp lk scr 3.5hex 4.75x15 st; lot#: 296340.Item#: 12-113560, compr 10mm hum fract stem pps; lot#: 438080.Item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 010240.Item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 140920.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 not provided.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.

• Brand Name: COMP RVS CNTRL 6.5X40MM ST/RST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15206577
• Report Number: 0001825034-2022-01844
• Device Sequence Number: 13980417
• Product Code: KWS
• UDI-Device Identifier: 00880304677104
• UDI-Public: (01)00880304677104(17)300425(10)941740
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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 Model Number: 115398
• Device Catalogue Number: 115398
• Device Lot Number: 941740
• 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: 07/14/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female