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); Not Applicable (3189); No Code Available (3191)

Event Date 04/11/2014

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

"the literature article entitled, "revision of ceramic head fracture after third generation ceramic-on-ceramic total hip arthroplasty" written by kyung-hoi koo, md, yong-chan ha, md, shin-yoon kim, md, kang-sup yoon, md, byung-woo min, md, and sang-rim kim, md published by the journal of arthroplasty 29 (2014) 214-218 was reviewed.The article's purpose: "we followed patients who underwent revision total hip arthroplasty specifically to treat a ceramic head fracture after third generation ceramic-on-ceramic tha.We evaluated the results, identified complications and suggest a potential guideline of the revision for contemporary ceramic head fractures." the article captures 24 patients in a table on page 215 but only 4 have depuy products and have been captured individually in linked complaints." this complaint captures patient #12 (b)(6) year old male with corail stem and unspecified acetabular component (assumed to be depuy) and received revision 23 months due to fracture of ceramic head with retained stem to a mop bearing change.He then experienced persistent thigh pain and 25 months after the index revision he was diagnosed with stem loosening (his radiographic image showed subsidence of 3 mm) and was revised to a longer stem, a ceramic head and poly liner.There is no indication that the migration was progressive and the diagnosis was stem loosening for revision reason.

Manufacturer 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 patient code: not applicable (3189) used to capture medical device removal.Additional patient code: pain - attachment: [(b)(4) guidance form.Xlsx, (b)(4).Literature article.Pdf].

• 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: 9282857
• MDR Text Key: 184851664
• Report Number: 1818910-2019-110986
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR