MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X30 ST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number 180553

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)

Event Date 10/22/2021

Event Type  Injury  

Event Description

It was reported the patient underwent a two stage revision arthroplasty of the left shoulder prosthesis approximately 16 months post revision arthroplasty due to infection, which caused loosening of the screws and led bone loss of the glenoid.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.No additional patient impact reported.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01511, 0001825034-2022-01512, 0001825034-2022-01515.Medical products: item#: 115398, comp rvs cntrl 6.5x40mm st/rst; lot#: 941740.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.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(6).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01511-1 0001825034-2022-01512-1 0001825034-2022-01515-1 the following sections were updated: a3; b4; b5; g3; g6; h1; h2; h3; h5; h6 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.

Event 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.

• Brand Name: COMP LK SCR 3.5HEX 4.75X30 ST
• Type of Device: 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: 14859072
• MDR Text Key: 295045016
• Report Number: 0001825034-2022-01510
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304677166
• UDI-Public: (01)00880304677166(17)300225(10)044810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 180553
• Device Catalogue Number: 180553
• Device Lot Number: 044810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female