MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ7 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157001135

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Injury (2348); Osteolysis (2377); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

The patient was revised to address pain.It was also indicated that hypertrophic tissue excised and normal cocr levels.

Event Description

Plaintiff fact sheet received.Pfs alleges pain, physical injuries, decreased range of motion and mobility, elevated metal ions, inflammation,infection (left hip), tissue damage caused by metal debris,unable to do normal activities, difficulty with stairs, walks with slight limp,cannot sit extended time and bend more than 90 degrees.

Manufacturer Narrative

(b)(4).

Event Description

Pfs and medical records received.Pfs alleges pain, physical injuries, decreased range of motion and mobility, elevated metal ions, inflammation, tissue damage caused by metal debris, unable to do normal activities, difficulty with stairs, walks with slight limp, cannot sit extended time and bend more than 90 degrees.After review of medical records for mdr reportability, patient was revised to address left hip adverse tissue reaction secondary to modular metal on metal total hip arthroplasty.Revision notes stated that there was erosion through the abductor and iliotibial band and markedly thickened capsule which was reactive and hypertrophic.Clinical visit reported pain, limb length discrepancy (left leg 1cm longer than the right leg),and discomfort.Mri showed marked soft tissue thickening.Radiographs showed some osteolysis at the neck region.Lab result shows metal ion levels above 7ppb.

Manufacturer Narrative

(b)(4).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 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7338146
• MDR Text Key: 102356145
• Report Number: 1818910-2018-55071
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2018

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 Expiration Date: 05/31/2011
• Device Catalogue Number: 157001135
• Device Lot Number: 107113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 04/10/2018; 04/12/2018; 11/28/2019
• Supplement Dates FDA Received: 04/17/2018; 04/27/2018; 12/13/2019
• Date Device Manufactured: 05/31/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109