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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Degraded (1153); Fracture (1260); Difficult to Insert (1316); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article entitled ¿modular stem fracture at stem-sleeve junction after primary total hip arthroplasty" written by junya yoshitani, takuya nakamura, yoshinobu maruhashi, takeshi sasagawa, kenichi ueshima, kiyonobu funakipublished by journal of orthopaedic science published online/accepted by publisher 4 october 2016 was reviewed.The article's purpose is to review a case study relating to s-rom-a components and the need for revision due to fractured stem.Data was compiled relating a (b)(6) year-old physically active healthy woman, weight (b)(6) kg, bmi 20.73 who received a primary tha of both hips for developmental dysplasia at age (b)(6).It is indicated the patient received s-rom-a components in her left hip.13/7 mm femoral stem, 12b-small sleeve, 28 / 3 mm cobalt-chromium head (depuy, warsaw, indiana).Also a highly cross linked polyethylene liner, and a 48 mm trilogy cup (competitor).The procedure was performed via a posterolateral approach, and no complications occurred intra and postoperatively.This article is focused on the patient left hip; right hip implants were not provided.Right hip adverse event or product deficiency is also not reported within this article.Pictures and radiographic images located on pages 2-3 relate to the (b)(6) year-old female¿s transverse femoral stem fracture.Depuy products: 13/7 mm femoral stem, 12b-small femoral sleeve, 28 / 3 mm cobalt-chromium head.Adverse events: ten years after implantation, when the patient was stretching, she complained of pain and heard an abnormal sound coming from her left hip.Transverse fracture of the femoral stem at the sleeve junction resulting in revision.Examination of the proximal stem surface, at revision, showed extensive scratching and circumferential black debris.This was assumed to represent severe corrosion.Fretting wear was observed at the trunnion surface.The proximal stem was easily removed from the sleeve.This suggests that the stem and sleeve did not connect proximally at the morse taper lock, and there was a crevice in the stem-sleeve interface.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the attached images confirmed the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 11013216
• MDR Text Key: 221744738
• Report Number: 1818910-2020-27016
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR