MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An article/literature was received entitled "a prospective randomised radiostereometric analysis trial of smartset hv and palacos r bone cements in primary total hip arthroplasty¿ on 13 may 2019: ¿a prospective randomised radiostereometric analysis trial of smartset hv and palacos r bone cements in primary total hip arthroplasty¿ was reviewed for mdr reportability.The study compared smartset hv and palacos r acrylic bone cements (without antibiotics) using third-generation cementing techniques in primary total hip arthroplasty.Thirty-five patients (36 hips) undergoing charnley total hip arthroplasty randomly received either of the two cements and were followed over a 24-month time-frame.Twenty-seven patients (28 hips) were reviewed 2 years postoperatively, 14 hips were cemented with depuy smartset hv cement.The following adverse events were noted: loosening, migration, and subsidence were reported without specific numbers; one patient suffered from cerebral infarction, which occurred in the immediate post-operative period.The patient fully recovered.It was noted two patients died: one due to multi-organ failure, the other a result of pneumonia.None of these patients had undergone a hip revision and the author noted none likely to be study related.Therefore, these two incidents will not be captured at this time.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8647463
• MDR Text Key: 146282632
• Report Number: 1818910-2019-94648
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention