MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 45MM; LPS AND S-ROM : KNEE ACCESSORY

Model Number	1987-07-045
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
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 SEGMENTAL COMPONENT 45MM
• Common Device Name: LPS AND S-ROM : KNEE ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10410567
• Report Number: 1818910-2020-18180
• Device Sequence Number: 14091449
• Product Code: JWH
• UDI-Device Identifier: 10603295078555
• UDI-Public: 10603295078555
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• 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: 1987-07-045
• Device Catalogue Number: 198707045
• Device Lot Number: C95002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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 POROUS STEM 16.5X125MM STR; LPS SEGMENTAL COMPONENT 30MM; LPS DISTAL FEM COMP XXSM RT; LPS POROUS STEM 16.5X125MM STR; LPS SEGMENTAL COMPONENT 30MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR