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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Migration (4003)

Patient Problems Pain (1994); Pocket Erosion (2013)

Event Date 03/03/2009

Event Type  malfunction  

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.Investigation summary.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.(b)(4).

Event Description

"literature article entitled, ¿distally locked, fully hydroxyapatite coated modular long stems in salvage revision hip arthroplasty: a report of early experience¿ by sivaraman subramanian, et al, published by european journal of orthopaedic surgical traumatology (2010), vol.20, pp.17-21, was reviewed.The purpose of this article is to present the authors¿ early experience using the reef femoral stem for revisions in 21 patients implanted between january 2005 and june 2007.The manufacturer of the revised stems, femoral heads, and acetabular components is unknown.Implanted depuy products: reef stem secured with 2 screws.The manufacturer of the femoral head is unknown results: 1 revision of a reef stem due to undersizing of the stem.The stem was revised to the correct, larger size.6 cases of radiologically identified heterotopic ossification-no treatment required.83 percent of cases showed radiologically identified spot welds- no treatment required.1 case of slight thigh pain and a 2-cm stem migration identified on radiological studies.No treatment was required, and the pain and stem migration were resolved at final follow-up.3 cases of intraoperative femoral cortex perforations that occurred during removal of the unknown cemented stem.The perforations are not attributed to the preparation for or insertion of the reef implants and are not included in this complaint.Captured in this complaint: 1 reef stem and 2 screws: implant fit: too loose; patient harms surgical intervention, medical device removal.1 reef stem and 2 screws: implant migration; patient harms: extraskeletal ossification, pain, medical device site erosion.".

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9420722
• MDR Text Key: 217439625
• Report Number: 1818910-2019-121164
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• 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 Sequence Number: 1