MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR PROLONG 36MM BRNG STD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	110031418
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery due to due to the implant subluxation and a bone fracture.The patient has been revised one previous time due to bone fracture.
Additional Manufacturer Narrative
(b)(4).Medical products: item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 555040; item#: 113628, comp primary stem 8mm mini; lot#: 092560.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Devices are used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse-type left shoulder arthroplasty is present.The glenoid implant appears unremarkable.There is subluxation of the humeral implant with widening of the prosthetic glenohumeral space seen on the ap view.There is also a mildly displaced fracture of the proximal humerus of uncertain acuity with proximal humeral cerclage wire fixation.Bone quality is osteopenic.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: CR PROLONG 36MM BRNG STD
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/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: 14552947
• Report Number: 0001822565-2022-01645
• Device Sequence Number: 4956694
• Product Code: KWS
• UDI-Device Identifier: 00887868231490
• UDI-Public: (01)00887868231490(17)240331(10)64299880
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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: 03/31/2024
• Device Model Number: 110031418
• Device Catalogue Number: 110031418
• Device Lot Number: 64299880
• 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: 05/17/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male