MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ5 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157012110

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Rash (2033); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Visual Impairment (2138); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167); Not Applicable (3189); No Information (3190); No Code Available (3191)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Patient was revised to address elevated ion levels.

Manufacturer Narrative

No device associated with this report was received for examination.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 will be filed as appropriate.

Event Description

Pinnacle litigation records received.Litigation alleges pain, elevated metal ions, metallosis, pseudotumor, physical injury, disability, lack of mobility, emotional distress, anxiety and depression.

Manufacturer Narrative

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, will be filed as appropriate.

Event Description

Pfs and medical records received.In addition to what were previously alleged, pfs alleges burning in the hip, rashes, vision problems and limited range of motion.It was also being alleged that blood clot from the revision surgery caused the left knee to swell and be very painful for 3 weeks.After review of medical records, the patient was revised to address elevated metal ions, osteolysis, pseudotumor, inflammation and synovitis.Operative notes reported whole area was stained with metallosis, pseudotumor, synovitis and fibrinous material that had been metal stained.Pseudocapsule was eroded.Doi: (b)(6) 2010.Dor: (b)(6) 2017.Left 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 DUOFIX TAP SZ5 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6457744
• MDR Text Key: 71680137
• Report Number: 1818910-2017-15945
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2017

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 Expiration Date: 01/12/2020
• Device Catalogue Number: 157012110
• Device Lot Number: EA8BJB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided; 04/19/2017; 04/19/2018; 09/19/2018; 12/27/2018; 07/30/2020
• Supplement Dates FDA Received: 05/22/2017; 05/07/2018; 05/16/2018; 10/01/2018; 01/03/2019; 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 109