MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 10X100MM STR; LPS AND S-ROM : KNEE STEMS

Catalog Number	198725110
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a depuy lps 10x100 cemented stem, part code 198725110, lot number a5jap1 was bent.This was explanted (b)(6) 2018 at (b)(6).This is considered serious harm due to the need for revision surgery, and will be reported to (b)(6).The device is available for investigation.Cement manufacturer is unknown.Doi: unknown - dor: (b)(6) 2018 (unknown side).
Additional Manufacturer Narrative
This is a duplicate report of 1818910-2018-66889.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS CEMENTED STEM 10X100MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7841488
• Report Number: 1818910-2018-68276
• Device Sequence Number: 1431301
• Product Code: JDI
• UDI-Device Identifier: 10603295079149
• UDI-Public: 10603295079149
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 198725110
• Device Lot Number: A5JAP1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention