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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
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.

 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11013216
MDR Text Key221744738
Report Number1818910-2020-27016
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/15/2020 Patient Sequence Number: 1
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