MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS FEM TO SLEEVE ADAPTER +5; LPS AND S-ROM : KNEE FEMORAL ACCESSORY

Model Number 1987-06-005

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

Patient Problems Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

(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 was admitted due to pain, swelling and a warm knee 4 days postoperatively.Surgeon performed thorough i&d, component exchange and placement of antibiotic beads.Aspiration prior to surgery led surgeon to believe it was infected.Components were not ingrown as they had only been in for 5 days.Loosening due to time in the body.It takes approximately 6 weeks for implants to ingrow, these had 4-5 days.The whole femur was replaced to include the pin.Doi: (b)(6) 2020, dor: (b)(6) 2020, right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: LPS FEM TO SLEEVE ADAPTER +5
• Type of Device: LPS AND S-ROM : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10733829
• MDR Text Key: 213008500
• Report Number: 1818910-2020-23287
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295078494
• UDI-Public: 10603295078494
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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: 1987-06-005
• Device Catalogue Number: 198706005
• Device Lot Number: J58K78
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 35MM; LPS UNIV TIB HIN INS XXSM 12MM; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X16MM FLUTED; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 35MM; LPS UNIV TIB HIN INS XXSM 12MM; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X16MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 104