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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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. .
Event or Problem Description
On (b)(6) 2019, the patient had a right total hip arthroplasty to address primary osteoarthritis, end-stage.Depuy components were implanted during this procedure.On (b)(6) 2021, the patient had a revision right total hip arthroplasty, to address failed right total hip arthroplasty secondary to aseptic loose femoral stem.The post-operative diagnosis was well-fixed femoral stem.The indications for surgery included: pain, limited ability to walk and exercise.Preoperative radiographs were reported to show subsidence of the stem.During the procedure, the surgeon observed that the stem has subsided slightly, but was well-fixed.The acetabular cup was noted to be well-fixed and there was no evidence of any adverse reaction to wear debris.The stem and the acetabular cup were not revised.The acetabular liner and head were revised.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2020, (right hip).

• Brand Name: SUMMIT POR TAPER SZ8 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11594809
• Report Number: 1818910-2021-06599
• Device Sequence Number: 3498060
• Product Code: LPH
• UDI-Device Identifier: 10603295060093
• UDI-Public: 10603295060093
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K001991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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: 1570-11-150
• Device Catalogue Number: 157011150
• Device Lot Number: J2944M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/31/2021
• 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: ALTRX +4 NEUT 36IDX62OD; DELTA CER HEAD 12/14 36MM +8.5; PINNACLE SECTOR II CUP 62MM; SUMMIT POR TAPER SZ8 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 113