MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157001110

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

Patient Problems Bruise/Contusion (1754); Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348)

Event Date 05/25/2017

Event Type  Injury  

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

Pinnacle litigation records received.Litigation alleges pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, metal toxicity, bone erosion, pseudotumors, implant failure, bursitis, nerve damage and emotional distress.Doi: (b)(6) 2005 ; dor: (b)(6) 2017 (left hip).

Manufacturer Narrative

(b)(4).

Event Description

Pfs and medical records received.Pfs alleges no new information.After review of medical records for mdr reportability, operative notes indicate that the patient was revised due to metallosis of left hip status post remote metal on metal total hip arthroplasty, elevated serum cobalt and chromium.Progressive pain and marked elevation of serum cobalt chromium ions were also reported in the revision operative notes.It was also noted that the wound had a relatively minor degree of metallic staining of the soft tissues, particularly around the acetabular component, however there was no substantial staining of joint fluid.Clinic visits further show that patient suffered from peri-incisional ecchymosis, discomfort, difficulty sleeping and pain post implantation.

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.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.

Manufacturer Narrative

(b)(4).

Event Description

In addition to previous allegations, ppf alleges metal wear and elevated metal ions.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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 will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ5 STD 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: 7189219
• MDR Text Key: 97311466
• Report Number: 1818910-2018-51181
• 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: 12/21/2017

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: 04/14/2010
• Device Catalogue Number: 157001110
• Device Lot Number: ZN6E31000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 02/05/2018; 08/06/2018; 12/28/2018; 12/09/2019
• Supplement Dates FDA Received: 02/15/2018; 08/27/2018; 01/08/2019; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 120