MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CONTROL CABLE W/CABLE SLEEVE; HIP MISCELLANEOUS : CABLE/WIRE

Model Number 1739-28-000

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

Patient Problem Unspecified Infection (1930)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient appeared to be infected and the surgeon chose to perform a single stage revision with dual set up and placement of resorbable antibiotic beads.Implants were not loose, however neither sleeve was ingrown further confirming presence of infection.Cement used was likely depuy 2 with gent but it was hospital owned so no record of quantity or lot info.(some components were implanted on (b)(6) 2021 when a femoral side revision was performed.A der was submitted but i do not have a number.) there was no surgical delay.Doi: (b)(6) 2021; dor: (b)(6) 2022; affected side: right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CONTROL CABLE W/CABLE SLEEVE
• Type of Device: HIP MISCELLANEOUS : CABLE/WIRE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13666578
• MDR Text Key: 286575780
• Report Number: 1818910-2022-04088
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10603295067788
• UDI-Public: 10603295067788
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

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: 1739-28-000
• Device Catalogue Number: 173928000
• Device Lot Number: JG2871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 03/26/2022; 04/05/2022
• Supplement Dates FDA Received: 04/01/2022; 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Treatment: ATT REV SLV LPS FEM ADP +0; ATTUNE REV LPS INSRT XXSM 12MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; LPS DISTAL FEM COMP XXSM RT; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 72 KG