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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Test Result (2695); No Code Available (3191)

Event Date 04/10/2016

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 entitled, "the effectiveness of blood metal ions in identifying patients with unilateral birmingham hip resurfacing and corail-pinnacle metal-on-metal hip implants at risk of adverse reactions to metal debris".Literature article entitled, ¿the effectiveness of blood metal ions in identifying patients with unilateral birmingham hip resurfacing and corail-pinnacle metal-on-metal hip implants at risk of adverse reactions to metal debris¿ by gulrau s.Matharu, bsc, mbchb, mres, et al, published by the journal of bone and joint surgery (2016), vol.98-a, no.8, pp.617-626 was reviewed for mdr reportability.This study involved patients with two commonly implanted metal-on-metal hip designs: birmingham hip resurfacing (bhr) and corail-pinnacle (depuy synthes) total hip replacement.The study had two aims: (1) to investigate whether blood metal ion thresholds could effectively identify patients at risk of adverse reactions to metal debris, and (2) to determine whether the cobalt-chromium ratio, when compared with using cobalt and chromium alone, was any more effective for identifying patients with adverse reactions to metal debris.Between august 1997 and may 2013, 3988 patients at one specialist center received 4816 primary metal-on-metal hip implants (3792 resurfacing and 1024 total hip replacement).Of the 3792 resurfacing implants, 87% (3299) were bhr implants.Five different metal-on-metal total hip replacement designs were implanted at this center on the basis of surgeon preference; the majority (578 [56%]) of these 1024 total hip replacements were corail-pinnacle implants.The corail femoral stem is a fully hydroxyapatite-coated titanium alloy stem with a 12/14 taper onto which a cobalt-chromium alloy femoral head is impacted, which articulates with a metal liner.The bhr implant and corail-pinnacle total hip replacement were the only implant designs assessed in this study.There were 598 patients with metal-on-metal hip implants (309 bhr implants and 289 corail-pinnacle implants) eligible for inclusion.Patients with the corail-pinnacle implant had significantly higher cobalt concentrations (p = 0.0010) and cobalt-chromium ratios (p < 0.0001) compared with patients with the bhr implant.Patients with the bhr implant had significantly higher chromium concentrations (p = 0.0012) compared with patients with the corail-pinnacle implant (fig.2).For the whole cohort, all three blood metal ion parameters were significantly higher (all p < 0.0001) in the group that had adverse reactions to metal debris compared with the group that did not.Blood metal ion thresholds for concern proposed by the united states (3 mg/l and 10 mg/l)15 and the u.K.Mhra (7 mg/l)5 were applied to the cohort and were compared with our implant specific thresholds in terms of the diagnostic test characteristics for identifying patients with adverse reactions to metal debris and the proportion of patients with adverse reactions to metal debris who were not identified by each threshold.The study found 20 pinnacle-corail patients with adverse reactions to metal debris which was defined as revisions needed or radiographically confirmed pseudotumors or excess fluid within the joint capsule.The article does not separate how many patients were revised from those who were not nor does it identify which components were revised and or affected.The authors do not identify the component sources of the elevated ions in the blood or the armd.There is no specific identification of the types of metal debris found intraoperatively.This was a retrospective study of patient charts and national registry information.The authors conclude by suggesting a lower co and cr threshold when testing for elevated ions when attempting to identify armd.

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.

• 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 Key: 8985062
• MDR Text Key: 161691396
• Report Number: 1818910-2019-103877
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention