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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Loss of Range of Motion (2032); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)
Event Date 11/29/2016
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
Literature article received titled, " risk factors for failure of the 36 mm metal-on- metal pinnacle total hip arthroplasty system".Literature article entitled, ¿risk factors for failure of the 36 mm metal-on-metal pinnacle total hip arthroplasty system a retrospective single-centre cohort study¿ by g.S.Matharu, et al, published by the bone and joint journal (may 2017), vol.99-b, no.5, pp.592-600 was reviewed for mdr reportability.The authors aimed to determine the cumulative all-cause failure rate at ten years following implantation of the 36 mm mom pinnacle tha system and identify risk factors for failure, with specific focus on the newly identified predictors.This retrospective single-center cohort study included patients treated with a primary mom pinnacle tha implanted between 2004 and 2010.All patients received a cementless corail femoral stem (depuy).For the present study only hips receiving a 36 mm diameter articul/eze femoral head (depuy) were included.There were 569 primary 36 mm mom pinnacle thas (504 patients) eligible for study inclusion.20 of these patients have been reported on previously, with information regarding the implants used, surgical procedure, patient follow-up, and blood metal ion analysis described in detail in pc-(b)(4), mirf-(b)(4).This report will only include patient consequences and pes that were not listed in the previous study.Specifically, the previous study in included 20 patients with armd, elevated metal ions, and pseudotumor.In this study, failures occurred in 77 hips (97 minus the 20 previously reported) at a mean time of 6.0 years (0.01 to 12.2) from primary arthroplasty.These failures consisted of 75 all-cause revisions and 22 additional armd imaging failures under surveillance.Armd was the most common indication for failure (n = 72; 74.2% of all failures) and for revision surgery (n = 50; 66.7% of all revisions).Non-armd revision indications were aseptic loosening (n = 8; 10.7%), infection (n = 6; 8.0%), dislocation (n = 5; 6.7%), and other (n = 6; 8.0%).The other category is not defined within the text of this article.Pseudotumor volumes ranged from 30 cm3 to 192 cm3.The remaining two armd imaging failures were pathological effusions.These were cystic collections (volumes between 25 cm3 and 30 cm3), with blood cobalt concentrations of 8.1 g/l and 9.2 g/l respectively.The authors conclude with the recommendation that patients implanted with the pinnacle system from the year 2007 forward have regular evaluations of blood ions and radiographic follow-ups because those implants have a statistically higher revision rate.They postulate that there may be a manufacturing issue with the cup, but were unable to confirm that hypothesis.Patient harms and specific products were not identified within the text of this article.20 of these patients have been reported on previously, with information regarding the implants used, surgical procedure, patient follow-up, and blood metal ion analysis described in detail in pc-(b)(4), mirf-(b)(4).This report will only include patient consequences and pes that were not listed in the previous study.Specifically, the previous study in included 20 patients with armd, elevated metal ions, and pseudotumor.
 
Manufacturer Narrative
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.Product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN HIP FEMORAL HEAD
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8985155
MDR Text Key161785481
Report Number1818910-2019-103881
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 08/26/2019
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 HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/26/2019
Initial Date FDA Received09/10/2019
Supplement Dates Manufacturer Received09/16/2019
Supplement Dates FDA Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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