MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ10 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-180

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Swelling (2091); Anxiety (2328); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 05/10/2017

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.Occupation: is a non-healthcare professional.(b)(4).

Event Description

Litigation alleges pain, stiffness, discomfort, weakness, affected mobility, anxiety, toxicity of metal, elevated metal ions and emotional distress.Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip.

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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.¿ added: a2 (age), b5, b6, b7, d7, d11 and h6 (patient).Corrected: h6 (device).

Event Description

After review of medical record, patient was revised to address increasing pain, right thigh abscess and infection.It was stated that the patient had increasing pain and unable to walk.Ct scan showed abscess, lysis and was found to have mssa bacteria.Revision notes reported, the patient's tissues were noted to be hyperemic and edematous.There was purulent obtained approximately 300 ml and small amount within the hip joint itself.There was extensive osteolysis along the posterior aspect of the femoral stem and around the rim of the cup.There were approximately 3 very large cystic cavities of the floor of the acetabulum, filled with yellow appearing necrotic bone.There was small amount of dark staining of the femoral stem, but there was minimal debris on the trunnion itself.Operative samples noted acetabular debris.

• Brand Name: SUMMIT POR TAPER SZ10 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8381924
• MDR Text Key: 137530687
• Report Number: 1818910-2019-86192
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295059417
• UDI-Public: 10603295059417
• Combination Product (y/n): N
• PMA/PMN Number: K170339
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

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 Model Number: 1570-01-180
• Device Catalogue Number: 157001180
• Device Lot Number: BS6GG1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/04/2019; 07/23/2020
• Supplement Dates FDA Received: 03/11/2019; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 62.; ASR TAP SLV ADAP 12/14 -1.; ASR UNI FEMORAL IMPL SIZE 55.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 97