MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 S-ROM*STM STD,30 NK,16X11X150; HIP FEMORAL STEM/SLEEVE

Catalog Number 523292

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Scarring (2061)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

Depuy synthes has been informed that the catalog number and lot number is not available.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Litigation alleges patient underwent a revision to address pain and excessive levels of chromium and cobalt.

Manufacturer Narrative

The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy still considers this case closed to capa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update - 08/08/2016 : supplemental information received; product part/lot updated.

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

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.

Event Description

Update ad (b)(6) 2018: (b)(4) has been re-opened under (b)(4) due to receipt of medical records.After review of medical records for mdr reportability it was reported that the patient was revised to address worsening increased of metal ion levels.Revision note stated, there was scarring in the posterior structures from her prior surgery.The joint fluid was clear without evidence of purulence, no evidence of metallosis.There were no laboratory values provided for the elevated metal ion levels.Doi: (b)(6) 2008 : dor: (b)(6) 2016 (right hip).

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 5689316
• MDR Text Key: 46228348
• Report Number: 1818910-2016-20293
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K061221
• 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: 05/13/2016

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: 09/28/2015
• Device Catalogue Number: 523292
• Device Lot Number: 2581313
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 05/31/2018; 09/18/2018
• Supplement Dates FDA Received: 06/22/2016; 09/02/2016; 06/07/2018; 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR