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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/24/2019

Event Type  malfunction  

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, "observed effect of femoral component under sizing and a collarless design in the development of radiolucent lines in cementless total hip arthroplasty" written by paul magill, md, janet hill, meng, phd, seamus o¿brien, rn, phd, michael stevenson, phd, alain machenaud, md, and david beverland, md published by arthroplasty today accepted by publisher on 24 november 2019 was reviewed.The article's purpose was to determine the number of subset of patients with a discordance between good clinical scores and radiographs with radiolucent lines (rlls) in all 4 proximal gruen zones and to identify possible risk factors for developing this pattern and whether or not there is a relationship between the presence of rlls and the oxford hip score.Data was compiled from 636 patients over a period of 17 months time.Depuy corail stems and pinnacle cups are identified with a study focus comparison of the collarless verse collared design and the correlation of radiographic findings of radiolucent lines in beyond the 2 "safe zones" and if there were clinical findings of associated pain.Results indicated some reports of pain and findings of radiolucent lines but no revisions or interventions were provided.The article's discussion further suggests that the collarless design group has 2 osteolytic risk factors of use of ceramic-on-metal bearing surfaces and findings of under sizing of stem by 2 sizes but no impact on patient clinical outcomes and the overall clinical outcomes were satisfactory.The article does not indicate that osteolysis was detected radiographically but only suggested the collarless design had risk factors.Radiographic images in figure 1 demonstrate findings of radiolucent lines.Depuy products: corail stem (collared and collarless designs), pinnacle cup, ceramic heads and metal liners.Adverse events: patient reports of pain (no interventions provided).Radiographic findings of radiolucent lines (no interventions provided).Radiographic findings of undersized stems by 2 sizes (no interventions provided).

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.

• 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: 9972505
• MDR Text Key: 191606244
• Report Number: 1818910-2020-10904
• 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
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1