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 Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 01/19/2017

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.(b)(4).

Event Description

"literature article entitled, ¿total hip replacement revision in a single brand small cementless stem ¿ our experience after the findings of the national joint registry¿ by robert pearce piggott, et al, published by the archives of bone and joint surgery (2018), vol.6, no.6, pp.501-507, was reviewed.The purpose of this article is to review the national joint registry to investigate the rate of revision and reasons for revision in our cohort of small corail stems.This complaint will capture the reasons for revision for 6 individual patients outlined within the text of this article.All patients were implanted with depuy acetabular components, femoral heads, and size 9 corail stems.Patient 1: (b)(6) female received a duraloc 56-mm cup revision due to pain and recurrent dislocations secondary to inadequate cup inclination.Impacted products: duraloc cup; malposition.Clinical symptoms: pain and joint dislocation.Health impact codes: medical device removal and surgical intervention.Patient 2: (b)(6) female implanted with an asr-xl cup, head, and femoral augment paired with a corail stem.Asr components were revised at 52 months due to pain, foreign body reaction and elevated blood metal ions (co 13.7 ppb and cr 10.6 ppb).There was no reported product problem with the retained corail stem.There were no reported product problems with the explanted asr-xl components.Impacted products: asr-xl cup, head, and augment and corail stem.Patient codes: surgical intervention, medical device removal, pain, blood heavy metal increased, and foreign body reaction.Patient 3: (b)(6) male patient implanted with an asr-xl cup, head, and femoral augment paired with a corail stem.Complete thr revision at 84 months due to pain, elevated blood metal ions (co 34 ppb and cr 26.5 ppb) and aseptic stem loosening secondary to aval.Impacted products: corail stem- implant loosening; asr-xl cup, head, and segment: no reported product problem.Patient codes: surgical intervention, medical device removal, pain, blood heavy metal increased, foreign body reaction.Patient 5: (b)(6) male received a revision of the corail stem at 1 month due to pain and early periprosthetic fracture secondary to a fall.There was no reported product problem with the explanted corail stem.Impacted products: size 9 corail stem.Patient codes: fall, fracture, pain, surgical intervention, medical device removal.Patient 4: (b)(6) male patient implanted with a 56-mm duraloc cup, cocr femoral head, polyethylene liner, and size 9 corail stem.Complete revision at 118 months due to pain and aseptic cup and stem loosening secondary to polyethylene liner wear and osteolysis.There was no reported product problem with the femoral head.Impacted products: duraloc cup: implant loosening; polyethylene liner: implant bearing wear; femoral head: no reported product problem; corail stem: implant loosening.Patient codes: pain, surgical intervention, medical device removal, osteolysis.Patient 6: (b)(6) female patient revised liner, head, and stem at 6 years due to pain and aseptic loosening of the stem.There were no reported product problems with the liner and head that were revised to accommodate the new stem.Impacted products: corail stem: implant loosening; liner and head: no reported product problem.Patient codes: medical device removal, surgical intervention, inadequate osseointegration, pain.".

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.Product complaint # (b)(4).Investigation summary: 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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9603085
• MDR Text Key: 185602663
• Report Number: 1818910-2020-02158
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention