MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN DEPUY FEMORAL STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Tissue Damage (2104); Joint Disorder (2373); No Code Available (3191)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unavailable.Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address pain and loosening of the pinnacle cup at the bone to implant interface.The cup migrated thru the medial wall.Prior xrays were not available so it is unknown if the cup migrated to that position or it was put there.A significant amount of "metal disease" was also noted in the joint from the metal on metal construct, but the surgeon said that the metallic debris could be from the trunnion of the femur hitting the cup.

Manufacturer Narrative

Product complaint: (b)(4).Depuy considers the investigation closed at this time.Should the 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.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.

• Brand Name: UNKNOWN DEPUY FEMORAL STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN 46582
• Manufacturer Contact: chad gibson ; st. anthony's road; leeds, IN ; UK ; 5743725905
• MDR Report Key: 6965034
• MDR Text Key: 89830697
• Report Number: 1818910-2017-27051
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 53 YR
• Patient Weight: 56