MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ6 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011120

Device Problems Corroded (1131); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Tinnitus (2103); Dizziness (2194); Ambulation Difficulties (2544); No Information (3190); No Code Available (3191)

Event Date 06/27/2013

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.For any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Litigation received.Litigation alleges dislocation, metal debris, and elevated metal ion levels.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Event Description

Update (2/16/2017) - pfs and medical records received.After review of the medical records for mdr reportability, plaintiff alleges hip dislocations in 2010 and 2013, elevated cobalt and chromium levels, a limp and pain when walking extended distances.Revising surgeon indicated patient had dislocations, elevation of ions, and symptoms of tinnitus and dizziness.Operatively, surgeon noted "200-300 ml of slightly turbid yellow fluid.Did not have the appearance of pus." also noted that proximal femur was "completely denuded.Bone itself was slightly discolored and had very little vascularity visible".Identified the gluteus medius and the vastus lateralis adhered to the fascia.Noted within the joint space a "copious amount of caseous material".Identified corrosion at the base of the femoral head and trunnion.Discovered copious amounts of black material along with fibrinous material between liner and shell.Stated that he felt "this was likely the greatest source of visible source of metal ions".No evidence of implant loosening noted.Post-op diagnosis read "symptomatic increased cobalt and chromium levels following metal-on-metal right total hip arthroplasty, plus abductor mechanism failure".No metal ion labs available in record to corroborate allegations of elevated ions.Prod/lot updated.

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Dislocated right hip on (b)(6), 2010 and again on (b)(6), 2011 due to the defected condition of the aforesaid device.

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.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

(b)(4).

Event Description

Ppf alleges metallosis.

Event Description

Ppf alleges loosening of cup.Added cup and screws due to loosening.However, medical records stated that there is evidence of implant loosening.Corrected code for metallosis to foreign body reaction.

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.Udi: (b)(4).Added: b5.Corrected: h6(patient).

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5590761
• MDR Text Key: 43096710
• Report Number: 1818910-2016-17673
• 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: 02/16/2017

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: 12/22/2009
• Device Catalogue Number: 157011120
• Device Lot Number: Y89DK1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 01/31/2016; 01/31/2018; 09/05/2018; 02/27/2019; 09/06/2019
• Supplement Dates FDA Received: 05/31/2016; 03/09/2017; 04/13/2017; 02/07/2018; 02/13/2018; 09/28/2018; 03/06/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 86