MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; SHOULDER, PROSTHESIS

Catalog Number 010000589

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7501625, comp rvs cntrl 6.5x35mm st/rst cat: 115397 lot: 66298867, comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 66138768, comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 66138768, comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 66058903, comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 66058896, comp primary stem 7mm std cat: 113647 lot: 65116055, comp rvs tray co 44mm cat: 115370 lot: 6618095.Arcom xl 44-36 std +3 hmrl brg cat: xl-115364 lot: 66236727.G2: foreign: denmark.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.

Event Description

It was reported that the patient was revised approximately one day post implantation due to implant disassociation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Type of Device: SHOULDER, PROSTHESIS
• 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: 18639043
• MDR Text Key: 334499673
• Report Number: 0001825034-2024-00264
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

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 Catalogue Number: 010000589
• Device Lot Number: 65847412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female