MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM PRODIGY

Catalog Number UNK HIP FEMORAL STEM PRODIGY

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Laxity (4526); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: (b)(6), whitehouse mr, greidanus nv, garbuz ds, masri ba, duncan cp.Revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications.Bone joint j.On (b)(6) 2018;100-b(6):720-724.Doi: 10.1302/0301-620x.100b6.Bjj-2017-1466.R1.Pmid: 29855241.Objective and methods: fretting and corrosion at the modular head/neck junction, known as trunnionosis, in total hip arthroplasty (tha) is a cause of adverse reaction to metal debris (armd).We describe the outcome of revision of metal-on-polyethylene (mop) tha for armd due to trunnionosis with emphasis on the risk of major complications.All the primary procedures were undertaken between july 2005 and march 2013 and all revisions occurred between november 2011 and february 2017.A total of 33 patients with a mop tha who underwent revision for armd due to trunnionosis were identified.Of the 33 primary thas, three were manufactured by depuy and the remaining thirty were competitor products.The reasons for revision were pain, swelling, armd, trunnionosis, instability, pseudotumor, elevated metal ions, and corrosion of the head/neck taper junction.The 33 patients were all revised with competitor constructs.This complaint will only capture the events associated with the initial revision, as the remaining events were associated with competitor constructs.The article notes that an additional two patients received a depuy prostalac spacer to successfully treat pjis.There were no adverse events or product defects associated with the prostalac spacers.There is insufficient information within the text of this article to associate the reported reasons for revision with specific device manufacturer.There were a total number of 3 depuy tha constructs that were revised.It will be assumed that the reasons for revision are applied to all depuy devices.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: pinnacle cup and altrex liner, metal femoral head, 2 prodigy and 1 trilock stem.

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.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown.Therefore, a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP FEMORAL STEM PRODIGY
• Type of Device: FEMORAL STEM
• 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 Key: 17829580
• MDR Text Key: 324410999
• Report Number: 1818910-2023-19595
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• 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: 09/27/2023

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 Number: UNK HIP FEMORAL STEM PRODIGY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/19/2023
• 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 Number: 1
• Patient Outcome(s): Required Intervention