MAUDE Adverse Event Report: DEPUY (IRELAND) COLLARED; PROSTHESIS, HIP, HEMI, FEMORAL, METAL

Model Number 1010-11-030

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Toxicity (2333)

Event Date 03/21/2019

Event Type  Injury  

Event Description

Cross contamination of titanium with cobalt chromium depuy (b)(4): actis duofix stem (model 1010-11-030) (implant consists of two parts: stem + trunnion joined by a screw or other fixation) with porocoat and ha coating one or all of the above has a cross contamination issue.The femoral stem component actis duofix consists of a stem and trunnion (the section with the taper).The device "is composed of two or more separate segments designed to be joined, typically made of metal e.G., cobalt-chrome (co-cr), titanium (ti), stainless steel) and is coated with a material (e.G.Porous materials, ha.) depuy says the stem is ti-6 al-4 v eli alloy and ti porocoated and ha coated.Depuy regulatory affairs director and agents have never accounted for any distinctions of ti vs cocr between the stem and trunnion materials or the screw materials holding those two components together.Cobalt and chromium levels appearing in patient after implant.Patient has no occupational or environmental exposures.Stem has 12/14 taper but actis duofix is not listed in femoral head/stem compatibility chart with articul/eze biolox delta.The depuy orthopedics inc femoral head/stem compatibility chart shows no listing for their actis duofix stem be paired with the articul/eze taper 12/14 heads.All 12/14 tapers are not the same.The differences vary greatly in that the distances between the 12 end and the 14 end vary.Actis duofix stem is manufactured overseas by depuy ((b)(4)) and is an imported product and is one of the four components in the implant system with cross contamination issues.The cocr knee implants are manufactured in depuy (b)(4) so the cross contamination of products issues are a risk.This is not a mom/ metal on metal bearing surface issue and should not be confused with one because this stem is used in a cop/ ceramic on poly bearing.Depuy orthopedics, inc: pinnacle sector cup with gription coating (model 1217-32-050) 50mm continued diagnostics show cocr metal ion levels in blood/urine indicating that depuy synthes has a cross-contamination issue.No patient occupational or environmental hazard risks.Depuy synthes regulatory affairs supervisor/agent has failed to account for the cobalt, chromium and nickel in their allegedly titanium products.Depuy product literature "gription product rationale" (ca#dpem/ort/0513/0020) on p 4 "proven clinical heritage" reports depuy porocoat "is made by sintering a random array of spherical beads of titanium or cobalt chrome to an implant." pinnacle acetabular cups with gription coating are by the manufacturer's own accounting in their literature: titanium or cocr sintered beads.Cross contamination of cocr gription/ porocoat has occurred if the manufacturer letter dated 11/22/2019 claims the application on this pinnacle sector acetabular cup to be "titanium gription coating." (the cocr contaminant may also be in the "titanium porocoat coating" on the actis femoral stem (report id: med (b)(4)) which is paired with this pinnacle sector acetabular cup.The cross contamination of cocr in the reportedly titanium only products involves the coatings and/ or metal substrates, layers, or bases of one or more components which are joined together with a ball and liner bearing surface.The ball is ceramic and the liner is polyethylene, so this is not a mom surface bearing issue."pt product sticker may be diff, pt barcode scan may be diff." fda safety report id# (b)(4).

• Brand Name: COLLARED
• Type of Device: PROSTHESIS, HIP, HEMI, FEMORAL, METAL
• Manufacturer (Section D): DEPUY (IRELAND)
• MDR Report Key: 10163033
• MDR Text Key: 195744336
• Report Number: MW5095039
• Device Sequence Number: 2
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/12/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1010-11-030
• Device Catalogue Number: 101011030
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 56