MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC 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 Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Anxiety (2328); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 08/08/2017

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

Patient was revised to address metallosis.Doi: unknown; dor: (b)(6) 2017 (left hip).Update: 15 dec 2017: asr litigation record received.In addition to what was previously alleged, litigation alleges pain, stiffness, discomfort and weakness, limited mobility,metal toxicity and anxiety.Blood drawn revealed there was excessive levels of chromium and cobalt.Added unknown stem due to alleged metal toxicity.This complaint was updated on (b)(6) 2018.Doi: (b)(6) 2010; dor: (b)(6) 2017; left hip.

Manufacturer Narrative

(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

Added: (date of birth), (procode).

Manufacturer Narrative

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 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).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 : 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

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of the medical records the patient was revised to address metallosis, adductor disruption,pain, mom reaction and elevated metal ions.Operative note reported a large fluid collection, pseudomembrane, a balled trochanter devoid of abductor connection and granulous tissue.Trochanter had erosions.Pathology reported chronic synovitis with foreign body type granulomatous reaction.Clinical visit reported hip pain, waddling gait and elevated metal ions.

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.H6 patient code: no code available (3191) used to capture the surgical intervention and blood heavy metal.

• Brand Name: SUMMIT POR TAPER SZ7 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7183540
• MDR Text Key: 97013608
• Report Number: 1818910-2018-50968
• 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: 12/15/2017

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: 11/24/2017
• Device Catalogue Number: 157001135
• Device Lot Number: B62CK1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 06/19/2018; 06/18/2018; 12/10/2019; 04/27/2020; 05/20/2020
• Supplement Dates FDA Received: 02/07/2018; 06/20/2018; 06/28/2018; 12/10/2019; 05/05/2020; 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 129