MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REPLICA LG STAT LNG RT 15.0MM; HIP FEMORAL STEM/SLEEVE

Catalog Number 153055000

Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Synovitis (2094); Joint Swelling (2356); Test Result (2695); No Code Available (3191)

Event Date 12/04/2014

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.

Event Description

Update - 08/16/2016 pfs and medical records received.After review of the medical records for mdr reportability, the revision surgery notes report synovitis, adverse local tissue reaction and elevated serum cobalt chrome levels.Litigation alleges pain and swelling.The complaint was updated on: 09/08/2016.

Manufacturer Narrative

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

Event Description

Litigation received.Litigation alleges the patient suffers from pain, swelling, elevated cobalt levels and metallosis.There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

Pfs and medical records received.After review of the medical records for mdr reportability, the revision surgery notes report synovitis, adverse local tissue reaction and elevated serum cobalt chrome levels.Update rec'd 8/17/2016- litigation received.Litigation alleges the patient suffers from pain, swelling, elevated cobalt levels and metallosis.There is no new additional information that would affect the existing mdr decision.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.Should additional information be received the investigation will be reopened.

Event Description

Complaint description: pfs and medical records received.After review of the medical records for mdr reportability, the revision surgery notes report synovitis, adverse local tissue reaction and elevated serum cobalt chrome levels.Update rec'd 8/17/2016- litigation received.Litigation alleges the patient suffers from pain, swelling, elevated cobalt levels and metallosis.There is no new additional information that would affect the existing mdr decision.Update ad 11 sep 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheet records.Ppf has no new allegation.Added patient's address, law firm, surgeon and hospital.Doi: (b)(6) 2003 dor: (b)(6) 2014 (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).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: REPLICA LG STAT LNG RT 15.0MM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5935728
• MDR Text Key: 54171255
• Report Number: 1818910-2016-26752
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2016

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: 10/10/2007
• Device Catalogue Number: 153055000
• Device Lot Number: W4VEG1005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/12/2019
• Supplement Dates FDA Received: 09/13/2016; 10/14/2016; 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75