MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011135

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Toxicity (2333); Joint Swelling (2356); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.See section d for any product information received.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

The patient experienced debilitating pain, discomfort, and soreness, in the area of his hip implant, thereby, negatively affecting his ability to perform activities of daily living.On information and belief, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused toxic cobalt-chromium metal ions and particles to be released into the patient's blood, tissue and bone surrounding the implant.

Manufacturer Narrative

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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(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

Update may 03, 2017 legal medical records received.Pfs alleges difficulty with mobility gradually deteriorated affecting ability to bend, pain, soreness, and elevated metal levels.After review of the medical records for mdr reportability, it was reported that there was a notable inflammatory type tissue around tha.It was also reported that the right hip was confirmed to be longer than the left.No laboratory values for the alleged elevated metal levels.Part and lot information were provided.This complaint was updated on may 11, 2017.

Manufacturer Narrative

(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 will be filed as appropriate. .

Manufacturer Narrative

(b)(4).

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.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 SZ7 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5381739
• MDR Text Key: 36460007
• Report Number: 1818910-2016-11357
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/15/2016

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: Physician
• Device Catalogue Number: 157011135
• Device Lot Number: C3WHY1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/14/2018; 12/21/2018; 05/14/2019
• Supplement Dates FDA Received: 03/11/2016; 05/15/2017; 06/26/2018; 01/03/2019; 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 80