MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Muscular Rigidity (1968); Pain (1994); Scar Tissue (2060); Synovitis (2094); Tissue Damage (2104); Depression (2361); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

The patient was operated in 2005, with an asr prosthesis, due to a hip osteoarthritis of the left hip sequellar of the epiphysiolysis.The patient presented an epiphysiolysis of the left hip at the age of (b)(6).She was treated and operated in 1973.Then in 1986 for a varisation osteotomy of the right hip to equalise the length of the lower limb.Patient was revised following a post traumatic hip fracture where signs of metallosis and intolerance were noted during this revision.The patient incriminates the prosthesis implanted in 2005.Lower limb.Doi: (b)(6) 2005.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Investigation: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

Event Description

Claim letter alleges traumatic periprosthetic fracture, pain, limb asymmetry, stiffness, walking difficulty, scar, loss of mobility, depression and temporary functional impairment.Revision note reported synovitis, large granuloma, synovial psoas and metallosis.Lab results shows metal ion levels were above 7ppb.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Added: (patient code) 3191 no code available is for elevated metal ion levels.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8411584
• MDR Text Key: 138503037
• Report Number: 1818910-2019-86954
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR