MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS POROUS STEM 16.5X125MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-26-415
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	08/04/2020
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
Patient was revised due to fall and loosening of the femur & stem component at the bone to implant interface.Cement manufacturer used was unknown.Patient had lps implanted in (b)(6) 2019.Patient was revised using cemented lps stem.Doi: (b)(6) 2019 dor: (b)(6) 2020 right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.

• Brand Name: LPS POROUS STEM 16.5X125MM 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: 10410593
• Report Number: 1818910-2020-18182
• Device Sequence Number: 14091450
• Product Code: JWH
• UDI-Device Identifier: 10603295079309
• UDI-Public: 10603295079309
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1987-26-415
• Device Catalogue Number: 198726415
• Device Lot Number: C46190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 30MM; LPS SEGMENTAL COMPONENT 45MM; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 30MM; LPS SEGMENTAL COMPONENT 45MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR