MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-120

Device Problem Degraded (1153)

Patient Problems Wound Dehiscence (1154); Edema (1820); Foreign Body Reaction (1868); Nerve Damage (1979); Tissue Damage (2104); Discomfort (2330); No Code Available (3191)

Event Date 02/19/2020

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

It was reported that the patient was unstable.After review of medical records, the patient was revised to address metal on metal wear.There was gray-tinged fluid within the joint, corrosion on the femoral head-trunnion junction and only 75% of the abductor muscle's insertion was intact with some evidence of denervation and trunnions.Lab results note fluid collection, capsular dehiscence, an elevated cobalt level, discomfort and possible adverse tissue reaction to metal-on-metal bearing.Doi: (b)(6) 2009.Dor: (b)(6) 2020; (right hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ6 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: 9917388
• MDR Text Key: 187697066
• Report Number: 1818910-2020-10039
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060079
• UDI-Public: 10603295060079
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-11-120
• Device Catalogue Number: 157011120
• Device Lot Number: DJ4A11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUP 121722056/DN7ET1000; HEAD 136506000/2887438; LINER 121887456/2846464; SCREW 121725500/B4KCW4000; SCREW 121730500/C78FN4000
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 67