MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 40MM; LPS AND S-ROM : KNEE ACCESSORY

Model Number 1987-07-040

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Limb Fracture (4518)

Event Date 07/22/2021

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 implanted lps stem at femur has been broken.The x-ray showed that the implant and bone both fractured.Dor: (b)(6) 2021.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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: 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.H6 medical device problem code: appropriate term / code not available (a27) used to capture incident identified which might, directly or indirectly, lead to a temporary or permanent serious deterioration of a patient¿s, user¿s, or other person¿s state of health.

• Brand Name: LPS SEGMENTAL COMPONENT 40MM
• Type of Device: LPS AND S-ROM : KNEE ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12318706
• MDR Text Key: 266407366
• Report Number: 1818910-2021-17798
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295078548
• UDI-Public: 10603295078548
• 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: 07/30/2021

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: 1987-07-040
• Device Catalogue Number: 198707040
• Device Lot Number: HD4120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS CEMENTED STEM 12X125MM STR.; LPS DISTAL FEM COMP XSM LT.; LPS SEGMENTAL COMPONENT 40MM.; LPS UNIV TIB HIN INS XSM 14MM.; LPS CEMENTED STEM 12X125MM STR; LPS DISTAL FEM COMP XSM LT; LPS SEGMENTAL COMPONENT 40MM; LPS UNIV TIB HIN INS XSM 14MM
• Patient Outcome(s): Required Intervention