MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 G2 PRESS FIT STEM SZ2; HIP FEMORAL STEM/SLEEVE

Catalog Number 900000102

Device Problem Corroded (1131)

Patient Problem Foreign Body Reaction (1868)

Event Date 01/17/2017

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.(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

The revision surgery taken place due to numbness and paralysis in the legs caused by increased hydrops.During the surgery, minimal corrosion on the trunnion was found; it was not so much as the other similar cases.Pseudotumor was low, but large amounts hydrops like chocolate was in the hip joint.

Manufacturer Narrative

The complaint states primary tha for oa had taken place on (b)(6) 2007.Due to the problem caused by metal-on-metal, revision surgery will take place on (b)(6) 2017.Further information will be provided after the revision surgery.A complaint database search and review of manufacturing records did not identify any anomalies.The devices were reviewed by bioengineering.With regards to the head a taper score of (b)(4) was given.With regards to the liner; fine scratches of (b)(4) was identified and a goldberg taper score of (b)(4) was given.The head, and to a lesser extent the liner, were difficult to review due to the material on the device.The x-ray from 2016 shows 3 screws, shell and liner, head and stem.A single view was provided.No measurements were made.The stem appears well aligned but the lesser trochanter is superior to the lower edge of the pelvis indicating a possible leg length discrepancy.One screw is protrusio.Wear measurements on the head and liner were not possible due to the material on the parts.It is not possible to identify the root cause of the reason for revision.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep (b)(4).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.

• Brand Name: G2 PRESS FIT STEM SZ2
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6313919
• MDR Text Key: 66916729
• Report Number: 1818910-2017-12215
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 900000102
• Device Lot Number: 1887092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention