MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ1 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011070

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Erosion (1750); Cyst(s) (1800); Pain (1994); Scar Tissue (2060); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation records received.Litigation alleges injury, pain, elevated metal levels, fluid around the joint, loss of mobility and loss of enjoyment of life.Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).

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 will be filed as appropriate.

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.Device history lot: z4kfs1000.Device history batch: null.Device history review: no anomalies or deviations were observed.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

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

Sticker sheets, medical and implant records received.After review of medical records, the patient was revised to address adverse local tissue reaction secondary to metal debris with abductor tissue damage, failure of recalled total hip, elevated serum cobalt levels, and a large cystic collection consistent with adverse local tissue reaction secondary to metal debris as seen on mars-mri.Operative findings include significant amounts of scarring and fluid in the joint which was submitted for cell count and differential which had < 100 nucleated cells and was negative for infection.Synovial tissue was also sent for frozen section and again was negative for inflammation or infection.There was also anterior abductor muscle damage/erosion with blood tinged clear yellow fluid and mild metal staining of tissues.There was scratching on the surface of cup, femoral head and trunnion.Abundant metal debris was collected adjacent to the junction between the trunnion and sleeve.The stem was not revised and was left in situ.

• Brand Name: SUMMIT POR TAPER SZ1 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7600402
• MDR Text Key: 111007557
• Report Number: 1818910-2018-62129
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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: 05/18/2018

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: 157011070
• Device Lot Number: Z4KFS1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 08/13/2018; 05/13/2019; 07/18/2019
• Supplement Dates FDA Received: 07/20/2018; 09/10/2018; 05/16/2019; 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR