MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC. US PRODIGY SM STAT SHT LT 12.0MM; HIP FEMORAL STEM/SLEEVE

Catalog Number 152016050

Device Problems Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 02/24/2010

Event Type  malfunction  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ patient was revised to address instability.Update - (b)(6) 2011 - litigation papers allege after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.It is also alleged, as a result, patient has been experiencing severe pain and discomfort and inflammation in his both thigh and groin.It is further alleged he also experiences a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.Update 12/31/2014- pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated dislocations.The stem is being added for the alleged high metal ions (no lab results provided).There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 1/28/2015.

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.(b)(4).

Manufacturer Narrative

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ patient was revised to address instability.Update - 07/19/2011 - litigation papers allege after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.It is also alleged, as a result, patient has been experiencing severe pain and discomfort and inflammation in his both thigh and groin.It is further alleged he also experiences a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.Update 12/31/2014- pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated dislocations.The stem is being added for the alleged high metal ions (no lab results provided).There is no new additional information that would affect the existing mdr decision.The complaint was updated on:1/28/2015.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.

Event Description

Ppf alleges dislocation.

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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.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: PRODIGY SM STAT SHT LT 12.0MM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC. US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4460839
• MDR Text Key: 5189182
• Report Number: 1818910-2015-12098
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK000207
• 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
• Report Date: 12/31/2014

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 Expiration Date: 08/26/2018
• Device Catalogue Number: 152016050
• Device Lot Number: C3CAP1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided; 10/15/2018; 10/17/2019
• Supplement Dates FDA Received: 03/18/2015; 10/16/2018; 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 97