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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 56 HIP ACETABULAR CUP

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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 56 HIP ACETABULAR CUP Back to Search Results
Catalog Number 999804956
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Patient Problems Dyspnea (1816); Fatigue (1849); Foreign Body Reaction (1868); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Weakness (2145); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 09/08/2019
Event Type  Injury  
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. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. The complaint was received into the company with the following comment: the patient reports that the procedure and the rehabilitation was successful. August 2007: lumbar pain appeared. In 2008: hip pain appeared with abnormal noises which resonated throughout the leg. The analyses was revealed at least 3 kinds of infectious germs (b)(6) 2008 :a control radio was carried out, observing a the bascule of the pelvis. In 2009 : new symtoms: the patient was short, of breath at the slightest effort (difficulty to walk, to move due to fatigue and weakness of the operated leg) the patient was treated with analgesics. (b)(6) 2017: the control radio before the total hip revision. The report presents the hypothesis of a prosthetic detachment with formation of foreign body granuloma. (b)(6) 2017: patient has severe pain on a metal-metal hip prosthesis with a large head and bone destruction on the femur. 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 reported event is considered one of the possible complications of joint replacement. 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. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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
The patient reports that the procedure and the rehabilitation was successful. (b)(6) 2007: lumbar pain appeared. 2008: hip pain appeared with abnormal noises which resonated throughout the leg. The analyses was revealed at least 3 kinds of infectious germs. On (b)(6) 2008 :a control radio was carried out, observing a the bascule of the pelvis. In 2009 : new symptoms: the patient was short, of breath at the slightest effort (difficulty to walk, to move due to fatigue and weakness of the operated leg) the patient was treated with analgesics. On b)(6) 2017: the control radio before the total hip revision. The report presents the hypothesis of a prosthetic detachment with formation of foreign body granuloma. On (b)(6) 2017: patient has severe pain on a metal-metal hip prosthesis with a large head and bone destruction on the femur.
 
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Brand NameASR ACETABULAR IMPLANT 56
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds IN LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds IN LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9559505
MDR Text Key186202927
Report Number1818910-2020-00931
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number999804956
Device Lot Number2231157
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
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 NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 01/07/2020 Patient Sequence Number: 1
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