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 Problem Unspecified Infection (1930)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Concomitant med products and therapy dates: pinnacle gripton ac (shell), pinnacle dm metal liner, actis femoral stem, biolex ceramic femur, bimentum liner (b)(6) 2022.Model #: udi: the part number is unknown.All attempts to obtain product information were unsuccessful.Therefore, udi is unavailable.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 that approximately three weeks following a surgical procedure of the hip the patient developed a superficial wound that required reoperation after using an unknown adaptor device for femoral broaching.It was reported that the initial procedure lasted 67 minutes.It was reported that there was no interoperative complications during the initial procedure.It was reported that irrigation and debridement was needed to treat the wound.It was reported that the patient is recovering, and the event is being resolved.It was reported that the procedure was part of a kincise clinical study.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: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 15804084
• MDR Text Key: 303707030
• Report Number: 1045834-2022-01397
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility,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: 11/16/2022
• 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
• Date Manufacturer Received: 07/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White