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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 09/05/2017

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.

Event Description

The literature article entitled, "difference in trochanteric thickness between well-aligned and malaligned polished collarless stem" written by (b)(6) published by journal of clinical orthopaedics and trauma (2019), vol.10, pp.117-120 was reviewed.The article's purpose was to investigate the difference in trochanteric thickness between well aligned and maligned femoral stems.All stems were depuy cemented collarless polished c-stem.Cement manufacturer is unidentified and no other components are discussed.The data set was 95 hip replacements and the article clarifies 16 patients had stem in "varus malposition." figure 1 provides a radiographic image of a bilateral hip with left side with varus malposition stem and right side in neutral position.Depuy product: cemented c-stem.Adverse events: radiographically detected varus malpositioned stems (no interventions discussed, no further information 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: 10158679
• MDR Text Key: 195920411
• Report Number: 1818910-2020-13855
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention