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

Catalog Number 157011120

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Scarring (2061); Distress (2329); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reporter is an attorney.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 received.Litigation alleged high metal ions, pain, emotional trauma and distress.Doi: (b)(6) 2006; dor: not reported; right hip.

Manufacturer Narrative

(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).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.

Event Description

Mom hip revised due to pain and a fear of being poisoned by the metal ions.The contra lateral hip was also metal on metal and revised at (b)(6) on (b)(6) 2018.Since the revision on the left hip, her metal ion levels have returned to the normal range.No sign of metalosis in the right hip.The explants were retained by the patient for legal purposes.Doi: (b)(6) 2006.Dor: (b)(6) 2019.Right hip.

Event Description

Ppf, pfs and medical records received.Ppf alleges metal wear and pseudotumor.Pfs alleged scarring and limited mobility.After review of medical records, there were no revision notes provided.

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.Udi: (b)(4).

• 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: 7823246
• MDR Text Key: 118448250
• Report Number: 1818910-2018-67937
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/03/2018

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 Catalogue Number: 157011120
• Device Lot Number: AC6BH1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/28/2018
• Supplement Dates Manufacturer Received: 09/28/2018; 02/25/2019; 03/11/2019
• Supplement Dates FDA Received: 10/02/2018; 03/07/2019; 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 115