MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Limb Fracture (4518); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: whittaker rk, zaghloul am, hothi hs, siddiqui ia, blunn gw, skinner ja, hart aj.Clinical cold welding of the modular total hip arthroplasty prosthesis.J arthroplasty.2017 feb;32(2):610-615.Doi: 10.1016/j.Arth.2016.07.020.Epub 2016 aug 10.Pmid: 27665242.Objective and methods: authors performed a case-control study of consecutively received hip revision implant retrievals; and chose the design of the hip that had the greatest number of truly cold-welded heads (heads that could not be removed from trunnions during revision surgery, necessitating unintended removal of the femoral stems)¿this group of implants all had a titanium stem paired with a titanium taper (n = 11).For a control group, the authors chose retrieved hip implants of the same design but without cold-welding of the head (n = 35).They compared the clinical variables between these 2 groups using nonparametric mann-whitney tests to investigate the significance of differences between the cold-welded and non-cold-welded groups.The truly cold-welded group was entirely represented by competitor implants.In the non-truly cold-welded group, depuy was represented by asr acetabular constructs paired with corail stems (n = 4), pinnacle acetabular constructs paired with corail stem (n = 1) and s-rom stem (n = 1)¿the remaining 29 pairs were represented by competitor devices.Patient specific demographic or treatment information was not provided, nor was any case specific product/lot code information given.Results: reasons for revisions provided were non-specific to each case, but included unexplained pain, aseptic loosening of the femoral stem and/or cup, femoral bone fracture, osteolysis, calcar lysis, and gluteal atrophy.All revisions demonstrated elevated cobalt and chromium metal ion serum levels.The design that most commonly caused cold welding was a competitor system combination of a titanium stem and titanium taper: 11 out of 48 (23%) were truly cold welded.Comparison of the clinical data showed that no individual factor could be used to predict this preoperatively with none of the 4 predictors tested showing any significance: (1) time to revision (p =.687), (2) head size (p =.067), (3) patient age at primary (p =.380), and (4) gender (p =.054).Conclusion: clinical cold welding is most prevalent in titanium-titanium combinations of the stem and taper; 25% of cases received were cold welded.Analysis of clinical variables showed that it is not possible to predict which will be cold welded preoperatively.Surgeons should be aware of this potential complication when revising a titanium-titanium stem/head junction.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17307915
• MDR Text Key: 319006550
• Report Number: 1818910-2023-14005
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• 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