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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Literature article entitled, ¿reduced survival for uncemented compared to cemented total hip arthroplasty after operatively treated acetabular fractures¿ by john clarke-jenssen, et al, published by injury: international journal for the care of the injured (2017), vol.48, pp.2532-2539, was reviewed.The aim of the present study was to investigate the medium to long term implant survival and clinical results of a secondary tha after orif for acetabular fractures and to investigate any differences between cemented and uncemented components.The studied thas were implanted in 1993.The authors used implants from a variety of manufacturers.The authors provide information for the 11 patients who required revisions or reoperations.Patient 4 is excluded from this complaint because they were implanted with competitor products.The remaining 10 patients are detailed in the guidance document labeled case 1 through case 10.Case 1 is included on the parent pc-(b)(4) and the remaining cases are linked to this parent pc.Information regarding the implanted depuy products and associated adverse events are detailed in each case report.The cement used for cemented products was a competitor product.The competitor products are excluded from this complaint.Patient with cemented charnley polyethylene cup and femoral stem paired with a cocr femoral had a cup revision due to dislocation.The head and stem were left in situ.The cement used with the cup and stem was manufactured by a competitor.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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: 9351510
• MDR Text Key: 167319662
• Report Number: 1818910-2019-115086
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• 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
• Patient Outcome(s): Required Intervention