MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that patient was revised to address pinnacle mom.Loose srom at bone to implant interface.Broken stem.Doi: 2006, dor: (b)(6) 2020, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10748623
• MDR Text Key: 213475791
• Report Number: 1818910-2020-23447
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (PINNACLE HEAD); (PINNACLE LINER); (SROM SLEEVE); (PINNACLE HEAD); (PINNACLE LINER); (SROM SLEEVE)
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR