MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 16X125MM STR; LPS AND S-ROM : KNEE STEMS

Model Number 1987-25-416

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

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Weakness (2145); Heart Failure (2206); No Code Available (3191)

Event Date 01/09/2020

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 previously, a distal femur replacement had been carried out on (b)(6) 2020 with aseptic loosening and destruction of the distal femur.Doi: unknown; dor: (b)(6) 2020; right knee.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: LPS CEMENTED STEM 16X125MM STR
• Type of Device: LPS AND S-ROM : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9925010
• MDR Text Key: 186739593
• Report Number: 1818910-2020-10219
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295079217
• UDI-Public: 10603295079217
• Combination Product (y/n): N
• PMA/PMN Number: K033959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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: 1987-25-416
• Device Catalogue Number: 198725416
• Device Lot Number: HK9576
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS CEMENTED STEM 16X125MM STR; LPS DISTAL FEM COMP XSM RT; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 61MM; UNIVERSAL STEM 115X16MM FLUTED; UNK KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 78