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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 12/06/2004

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.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, ¿high wear rates and extensive osteolysis in 3 types of uncemented total hip arthroplasty: a review of the pca, the harris galante and the profile/tri-lock plus arthroplasties with a minimum of 12 years median follow-up in 96 hips¿ by geir hallan, stein a lie, & leif i havelin, published by acta orthopaedica (2006), vol.77, no.4, pp.575-584, was reviewed.The authors compare the wear rates and incidence and patterns of osteolysis in 4 cementless total hip systems as well as evaluating the influence of femoral head size, cup abduction, sex and body weight on wear rates, and the association between the rate of wear and the extent of osteolysis.The study was conducted between 1984-1994.There were depuy and competitor tha systems used in this study.Implanted depuy products: 50 profile stem, tri-lock cup, polyethylene liner, and 28-32-mm femoral heads implanted between 1989-1994.Results: 24 hips with extensive osteolysis- 9 treated with revision 1 mispositioned cup treated with revision 4 stem loosening secondary to osteolysis treated with revision 2 cup loosening secondary to osteolysis treated with revision 16 revisions of the liner due to polyethylene wear 1 revision of the tha due to pain and unspecified instability captured in this complaint: profile stem: implant loosening.Tri-lock cup: implant loosening, implant mispositioned.Polyethylene liner: implant bearing wear.Femoral head: no reported product problem.Patient harms: pint, joint instability, osteolysis, surgical intervention, medical device removal, inadequate osseointegration.".

Manufacturer Narrative

Product complaint # (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.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 complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4) appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Post market surveillance is per (b)(4).

• 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: 9367519
• MDR Text Key: 167772043
• Report Number: 1818910-2019-116858
• 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,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2019
• 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?: Yes
• Date Manufacturer Received: 11/18/2019
• 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