MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNKNOWN KINCISE ADAPTOR DEVICES; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number UNK-KINCISE-ADAPTORS

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

Patient Problems Nerve Damage (1979); Unspecified Tissue Injury (4559)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The brand name is unknown.The manufacturing location is unknown.The catalog number, lot/serial number, and unique identifier (udi) is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported from (b)(6) that a patient had a total hip replacement surgical procedure using the kincise system (an actis-stem was implanted).It was reported that after the surgery the patient was suffering from a peroneal lesion and a floppy foot.It was reported that the left hip of the patient had been affected.It was reported that an actis rasp size 4 was used, and an actis stem size 4 was implanted.It was not reported if there were any delays in the procedure or if a spare device available for use.There was patient involvement reported.It was not reported what and/or if medical intervention or prolonged hospitalization was required due to this event.There was no allegation of a malfunction against the device.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: UNKNOWN KINCISE ADAPTOR DEVICES
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 13052484
• MDR Text Key: 282568576
• Report Number: 1045834-2021-01923
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-KINCISE-ADAPTORS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 100 KG