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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Nonstandard Device (1420); Loss of Osseointegration (2408)

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 40 consecutive cementless total hip arthroplasties in 34 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, 24 females; 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 # 2 involves patient who was diagnosed with osteoarthritis underwent mom-asr revision after 26.7 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: infection, pulmonary embolism, dislocation, high estimated blood loss and rate of transfusions, aseptic loosening.Noted are the following product adverse events: implant loosening (stem).

Manufacturer Narrative

(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.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
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8876311
• MDR Text Key: 153805096
• Report Number: 1818910-2019-100584
• Device Sequence Number: 0
• Product Code: KWL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2019
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention