MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); 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.

Event Description

An article ¿mean 5 year clinical and radiographic outcomes of cementless total hip arthroplasty in patients under the age of 30¿ by jeremy m gililland et al reports a retrospective review of radiographic and clinical results following total hip arthroplasty in a series of 40 young patients under the age of 30 (16 males, 24females; mean age- 22 years) with advanced coxarthrosis primarily secondary to noninflammatory processes using modern cementless implants and bearing couples between 1996 to 2008.Following hip implants were used: taperloc and s-rom for femoral components; m2a or magnum, asr, pinnacle for acetabular components.Perioperative complications include relatively high estimated blood loss and rate of transfusions, dislocation (n=4), infection (n=1) and pulmonary embolism (n=1).This article also indicates two intra-operative fractures, but it does not specify the product (depuy or another) associated with these adverse events, and the information whether the fracture was patient bone or implant device.7 cases underwent to revision surgery in which depuy products were used in 4 cases (3 with mom-asr articulation (depuy srom and depuy asr); and 1 case with mop articulation (depuy srom and biomet rb)).2 of mom-asr articulation) out of 3 were revised due to metallosis while other one was due to aseptic loosening (acetabular and femoral component).One case of mop was revised due to periprosthetic femur fracture.No clarification was found on which events were specifically present on specific patients except implant used and adverse event.Asr was found to be associated with above reported adverse events.Case # 3 involves patient who was diagnosed with osteoarthritis underwent mom-asr revision after 60.8 months.Patient received revision for both components: depuy srom as femoral component and depuy asr as acetabular component (per table 3, page 4).Noted are the following patient adverse events: metallosis.Noted are the following product adverse events: foreign body reaction.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8876452
• MDR Text Key: 153806204
• Report Number: 1818910-2019-100594
• Device Sequence Number: 0
• Product Code: KWL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/29/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention