MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ8 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Psf and medical records received.After review of medical records patient was revised to addressed failed right metal on metal total hip arthroplasty with pseudotumor and osteolysis of proximal femur.Operative notes indicated pain, discomfort, walking difficulty, clicking, elevated metal ion levels, metallosis, swelling and significant metal debris as well within the greater trochanter had a fairly large area in that juncture.Doi: on or around (b)(6) 2002 - dor: (b)(6) 2017 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: SUMMIT POR TAPER SZ8 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10706557
• MDR Text Key: 212145784
• Report Number: 1818910-2020-22892
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060093
• UDI-Public: 10603295060093
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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
• Device Operator: Health Professional
• Device Model Number: 1570-11-150
• Device Catalogue Number: 157011150
• Device Lot Number: WR7CR1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +12; PINNACLE MTL INS NEUT36IDX56OD; PINNACLE SECTOR II CUP 56MM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +12; PINNACLE MTL INS NEUT36IDX56OD; PINNACLE SECTOR II CUP 56MM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR