MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/01/2017

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.Investigation summary: 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.

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) year-old 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) year-old 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) year-old 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) year-old 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) year-old 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) year-old 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.H10 additional narrative: corrected : h6.Product complaint # (b)(4).Investigation summary: 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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint # (b)(4).Investigation summary - 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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9603247
• MDR Text Key: 185769295
• Report Number: 1818910-2020-02173
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention