MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-52-000

Device Problem Corroded (1131)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Tissue Damage (2104); Weakness (2145); Test Result (2695); No Code Available (3191)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

Unf and medical records received.There were no allegation reported from unf.After review of medical records, patient was revised to address right hip adverse local tissue reaction due to metal on metal total hip replacement.Indication note reported weakness, cobalt level 140 and chromium level 100, and on x-ray there was protrusion of the shell.Operative note reported significant amount of necrotic tissue that had corrosion, abductor tissue loss, and there was corrosion on the taper, corrosion at the edge of the shell and liner, and the liner appeared cold welded to the shell, bone loss from the shell removal, pseudotumor and cysts.Doi: (b)(6) 2008; dor: (b)(6) 2019 (right hip) first revision.

Manufacturer Narrative

Product complaint # (b)(4).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.H6 patient code: no code available (3191) used to capture surgery prolonged patient code.Duplicate event was previously reported in (b)(4).Since it was not known that the current device was also revised at that time, the information from (b)(4) is now being incorporated in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the dr.Texted the sales rep and said "i have a metal on metal revision hip coming up i wanted to see what my headliner options were".After a brief phone call, the surgeon decided that he was going to try to preserve the cup, remove the metal liner and preoperative plan was to trial and replace liner with +4/10° and +9 32mm head.Dr.Could not remove metal liner using a ab extractor, reciprocating saw, and bone tamps.Dr.Decided to remove entire cut implant zimmer acetabular cup and liner and also implant +5 ts 32 mm head.Nothing was said about the metal on metal liner but there was an obvious understanding that it was an issue based on the explant and tissue surrounding the cup.There was a surgical delay of 1 hour and 30 mins.Doi: (b)(6) 2008, dor: (b)(6) 2019, right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTICULEZE M HEAD 36MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9636449
• MDR Text Key: 186612247
• Report Number: 1818910-2020-03157
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033936
• UDI-Public: 10603295033936
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2019

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 Expiration Date: 01/31/2013
• Device Model Number: 1365-52-000
• Device Catalogue Number: 136552000
• Device Lot Number: 2541572
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 03/13/2020; 03/13/2020
• Supplement Dates FDA Received: 03/13/2020; 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +5; ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX15MM; PINN SECTOR HA ACET CUP 50MM; PINN SECTOR HA ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT DUOFIX TAP SZ5 HI OFF; SUMMIT DUOFIX TAP SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR