MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; EXTREMITIES IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Metal Related Pathology (4530)

Event Date 07/31/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 110032410, comp aug mini bsplt w tpr s, lot # 64314041 catalog #: 115370, comp rvs tray co 44mm, lot # 403720 catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 606680 catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 504390 catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 427570 catalog #: 113631, comp primary stem 11mm mini, lot # 733660 catalog #: 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 919910 catalog #: ep-115393, e1 44-36 std hmrl brng, lot # 961790 h3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the has been requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02028, 0001825034-2023-02029, 0001825034-2023-02030, 0001825034-2023-02031, 0001825034-2023-02032, 0001825034-2023-02033, 0001825034-2023-02034, 0001825034-2023-02041 h3 other text : requested but not returned by hospital.

Event Description

It was reported the patient underwent a procedure approximately 4 years ago.Subsequently, the patient was revised about a month ago due to pain, reactive tissue, fluid in the capsule, and tissue between the baseplate and glenosphere.There is possible metallosis or allergy.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).H6: suggested component code annex g - mechanical (g04) - head.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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

No further event information available at the time of this report.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• Type of Device: EXTREMITIES IMPLANT
• 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: 17643711
• MDR Text Key: 322199153
• Report Number: 0001825034-2023-02027
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304475373
• UDI-Public: (01)00880304475373(17)290404(10)263010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 263010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 59 KG