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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL BODY

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DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL BODY Back to Search Results
Catalog Number UNK SHOULDER HUMERAL BODY
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Joint Dislocation (2374); Unspecified Tissue Injury (4559)
Event Date 01/01/2017
Event Type  Injury  
Event Description
Article entitled ¿reverse shoulder arthroplasty compared with hemiarthroplasty in the treatment of acute proximal humeral fractures¿ written by michael van der merwe, mbc, matthew j.Boyle, bs, mbchb, fracs, christopher m.A.Frampton, phd, and craig m.Ball, mbchb, fracs published in journal of shoulder and elbow surgery in 2017 was reviewed.The aim of this study was to provide an update to the previous paper of boyle et al by comparing the functional outcomes of rsa with hemiarthroplasty in the management of acute proximal humeral fractures.Among rsa patients, the most used prostheses were the smr modular shoulder (limacorporate s.P.A., udine, italy; used in 117 patients) and the delta xtend reverse shoulder system (depuy, warsaw, in, usa; used in 81 patients).Among hemiarthroplasty patients, the most used prostheses were the global (depuy; used in 210 patients), the global advantage humeral head (depuy; used in 197 patients), and the smr (used in 75 patients).It is unknown if the humeral stems were cemented or porous coated.Adverse events aren¿t specific to the depuy implants- the reasons for revision recorded by the new zealand joint registry included deep infection, pain, dislocation, fracture, implant loosening or failure, cuff tear, and stiffness.
 
Manufacturer Narrative
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNKNOWN SHOULDER HUMERAL BODY
Type of Device
SHOULDER HUMERAL BODY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key15525994
MDR Text Key301011129
Report Number1818910-2022-19279
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER HUMERAL BODY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2022
Initial Date FDA Received10/01/2022
Supplement Dates Manufacturer Received10/03/2022
Supplement Dates FDA Received10/04/2022
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 Number1
Patient Outcome(s) Required Intervention;
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