MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 15X125MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Edema (1820); Pain (1994); No Code Available (3191)
Date of Event	04/28/2019
Type of Reportable Event	Serious Injury
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 at this time.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.
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 on (b)(6) 2018, the patient slipped on the tile at her home and fell to the side.She did not strike her head or lose consciousness.Patient suffered a right femur fracture per imaging.Img to consult for perioperative medical risk stratification.Patient denies any chest pain, dyspnea, n/v/d, headache.On (b)(6) 2018, the patient underwent orif of a right periprosthetic femur fracture.Postoperatively, 2-1/2 weeks, the patient complains of burning and swelling around the right knee and towards the right lower extremity.On (b)(6) 2018, the patient reports that she was performing passive leg raises at home and felt something break at her previous surgical site.The patient is s/p orif right distal femur periprosthetic fracture.Pain was sharp, non-radiating and rated 10/10.On (b)(6) 2018, the patient complains left leg pain that started suddenly.She was doing exercise with pt at home and she was found to have fractured hardware.On (b)(6) 2019, patient with unfortunate nonunion.She has broken her hardware.She has failed hardware and a failed total knee arthroplasty and essentially a deformity of the knee w/ a painful right leg.She was admitted urgently because of the pain and the risk to the leg with the femoral fracture and loose metal.She underwent revision of right total knee arthroplasty, hardware removal on the right femur on the same day.On (b)(6) 2020 an email notification was received from synthes that there was depuy jrn device involved in this complaint.

• Brand Name: LPS CEMENTED STEM 15X125MM 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: 9693485
• Report Number: 1818910-2020-04445
• Device Sequence Number: 19391961
• Product Code: JDI
• UDI-Device Identifier: 10603295079200
• UDI-Public: 10603295079200
• Combination Product (Y/N): N
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1987-25-415
• Device Catalogue Number: 198725415
• Device Lot Number: H86998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/16/2020
• 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: 87 YR