MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 LPS CEMENTED STEM 10X100MM STR; LPS AND S-ROM : KNEE STEMS

Catalog Number	198725110
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient had an lps proximal tibial replacement 3 years ago for osteosarcoma.She had a recent fall and x-ray showed that the cemented stem was bent.The surgeon brought her back to the or to revise the stem.During the revision surgery, the stem was removed and a longer, bigger cemented stem was implanted.The surgeon feels that this implant should not have fatigued and bent this early on.Other primary implants remains insitu (srom femur xsm, 31 fem sleeve, 75x14 stem, lps prox tib, 35 and 40mm segment.10x100 cemented stem was exchanged for 12x125 cemented stem.Patient consequence? yes.Patient consequence description:required revision surgery.Action taken for procedure:bent stem and cement was removed and a longer, bigger cemented stem was implanted.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.An x-ray image representing the reported device was included for review.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7788895
• Report Number: 1818910-2018-66889
• Device Sequence Number: 19417230
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 198725110
• Device Lot Number: A5JAP1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 81