MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 STD OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157001090

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Osseointegration Problem (3003); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 11/13/2008

Event Type  Injury  

Event Description

Patient was revised to address periprosthetic fracture and stem loosening.

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).For any product information received.Depuy synthes has been informed that the catalog number and lot number is not available.

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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

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

Manufacturer Narrative

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.Corrective action was not indicated.Depuy considers the investigation closed.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 12/22/15- pfs and medical records received.Pfs and medial records were reviewed for mdr reportability.Pfs reported dislocation, leg length discrepancy, pain and trouble completing activities of daily living.The medical records reported that the patient had femoral stem revised and periprosthetic fracture repaired on (b)(6) 2008.It also reported that the femoral component had subsided and the patient had a fall.The dor on this com will be changed to (b)(6) 2008.The medical records also reported that the patient had a loose femoral component, periprosthetic fracture, recent fall, leg length discrepancy, pedestal at tip of stem and no obvious metallosis on revision surgical report dated (b)(6) 2014.A new complaint will be made for the dates (b)(6) 2008 to (b)(6) 2014.There was no report of dislocation.Lab results reported metal ion levels to be less than 7 parts per billion and no need to be reported.Part/lot updated.The complaint was updated on: jan 13, 2016.

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.  .

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.H10 additional narrative: added: h6 (device).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.

• Brand Name: SUMMIT POR TAPER SZ3 STD OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4362800
• MDR Text Key: 16089223
• Report Number: 1818910-2014-35151
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2014

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: 157001090
• Device Lot Number: CA7F71000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 08/09/2019; 02/05/2020
• Supplement Dates FDA Received: 02/17/2015; 11/17/2015; 01/14/2016; 01/15/2016; 08/12/2019; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 58