MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 11MM MICRO; EXTREMITY IMPLANTS

Model Number N/A

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: catalog #: 405800, comp.Rev shldr 9 in steinmann, lot # 130520 catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 886240 catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 437540 catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 098780 catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 918800 catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 855910 catalog #: 115398, comp rvs cntrl 6.5x40mm st/rst, lot # 655670 catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 656600 catalog #: 110031424, cr vivacit-e 36mm brng std, lot # 65434165 catalog #: 110031399, mini tray std cocr +0 offset, lot # 65398274 customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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: 0001825034-2023-00354, 0001825034-2023-00355, 0001825034-2023-00356, 0001825034-2023-00357, 0001825034-2023-00358, 0001825034-2023-00359, 0001825034-2023-00360, 0001825034-2023-00361, 0001822565-2023-00438, 0001822565-2023-00439 requested but not returned by hospital.

Event Description

It was reported that the patient was revised approximately 3 months post implantation due to an suspected nickel allergy.Attempts have been made and there is no further information at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.Only the steinmann pin contains nickel, which is the confirmed metal allergy allegation.This product is confirmed to not contain nickel; therefore, the initial report should be voided.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined to be not reportable.Only the steinmann pin contains nickel, which is the confirmed metal allergy allegation.This product is confirmed to not contain nickel; therefore, the initial report should be voided.

• Brand Name: COMP PRIMARY STEM 11MM MICRO
• Type of Device: EXTREMITY IMPLANTS
• 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: 16410305
• MDR Text Key: 309895038
• Report Number: 0001825034-2023-00362
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304554122
• UDI-Public: (01)00880304554122(7)320105(10)65319533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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: 113611
• Device Lot Number: 65319533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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