MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ #2 ETH CP-2 *EA; STAPLE, FIXATION, BONE

Catalog Number 212034

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

Patient Problem Foreign Body Reaction (1868)

Event Date 03/23/2021

Event Type  Injury  

Event Description

This is report 1 of 3 for (b)(4).It was reported by j&j employee that under synthes complaint (b)(4) usage of mitek devices (gii® quickanchor® plus, single pack) was identified.Event description: "it was reported that the patient was revised due to metalosis.Ultamet metal liner/head.The hip joint was black and green with metal debris.Additional information event in the der reported osteolysis.Product issues was suspected and contributed to the event.Doi: unknown: dor: (b)(6) 2021: left hip".

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: udi: (b)(4).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.E3: reporter is a j&j employee.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that an invalid lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If a valid lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17699373
• MDR Text Key: 322846872
• Report Number: 1221934-2023-03320
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001828
• UDI-Public: 10886705001828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 212034
• Device Lot Number: 3159986
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 80 KG