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 Type  Injury  

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.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, ¿reverse hybrid total hip arthroplasty: a survival analysis of 1082 consecutive cases with minimum five-year follow-up¿ by s.Jain, et al, published by the bone and joint journal (2018), vol.100-b, no.8, pp.1010-1017, was reviewed.This study aimed to evaluate implant survival of reverse hybrid total hip arthroplasty (tha) at medium-term follow-up.The 1082 thas used were implanted between december 2005-march 2012.Implanted depuy products: 415 charnley elite cups, 667 marathon polyethylene cups, 1082 corail stems, 832 metal femoral heads, and 250 ceramic femoral heads.Results captured in pc-000602172: 1 death due to postoperative pneumonia 8 dislocations treated with closed reduction 11 intraoperative unspecified periprosthetic fractures- 8 treated with cerclage and 3 required no intervention.The location of the fractures was not provided; therefore, this complaint captures the cup and the stem for fracture intra-op.3 venous thromboembolisms treated pharmacologically.1 sciatic nerve palsy that did not resolve at final follow-up.Treatment was unspecified.1 femoral nerve palsy that was completely resolved at 6 months.Treatment was unspecified.Captured in pc-000602172: 1 cup, head, and stem: death.Polyethylene cup: implant dislocation.Femoral head: implant dislocation.Corail stem: no reported product problem.Patient harms: nerve injury, joint dislocation, pneumonia, venous thromboembolism, fracture.Parent pc-000602172 will capture the complications that were not identified by patient.The 26 revisions are labeled case 1 through case 25 in the attached guidance document and linked to pc-000602172." (b)(6) female patient implanted with a cemented charnley elite polyethylene cup, 28-mm metal femoral head, and kla11 corail stem.The cement used to secure the cup was a competitor product.Revised the cup and head 6.28 years after index surgery due to recurrent dislocation.There was no reported product problem with the stem.

• 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
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9467417
• MDR Text Key: 185663685
• Report Number: 1818910-2019-123045
• Device Sequence Number: 1
• Product Code: KWY
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 11/20/2019
• 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
• Patient Age: 70 YR