MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011090

Device Problem Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Inflammation (1932); Pain (1994); Injury (2348)

Event Date 07/18/2017

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

Pinnacle claim letter and medical record received.Claim letter alleges extreme high levels of metal in the blood in which a metal debris was found on the patient's hip during revision surgery.It was also indicated that the plaintiff suffered from injuries and intend to seek damages.After review of medical records for reportability, patient was revised to address failed hip arthroplasty with metal-on-metal liner failure.Revision notes reported of extensive synovitis with metal debris in the hip and presence of cyst within the pubis.An mri confirms that there was significant soft tissue inflammation and the patient's cobalt and chromium levels were elevated.An mri confirms that there was significant soft tissue inflammation and the patient's cobalt and chromium levels were elevated.There were no laboratory results provided.Doi: (b)(6) 2009; dor: (b)(6) 2017; right hip (pinnacle).This pc is linked to (b)(4).

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.

Event Description

Litigation alleges significant damages, including but not limited to physical injury, economic loss, pain and suffering.

Manufacturer Narrative

Udi: (b)(4).

Event Description

Ppf alleges metallosis.

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.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Device history lot: null.Device history batch: null.Device history review: null.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 SZ3 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: 7285713
• MDR Text Key: 100556941
• Report Number: 1818910-2018-53832
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060048
• UDI-Public: 10603295060048
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/02/2018

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: 03/07/2019
• Device Catalogue Number: 157011090
• Device Lot Number: DG8A4A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/20/2018; 05/11/2018; 12/28/2018; 07/18/2019
• Supplement Dates FDA Received: 03/20/2018; 06/01/2018; 01/01/2019; 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR