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

Catalog Number UNK HIP FEMORAL STEM SUMMIT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Limb Fracture (4518); Metal Related Pathology (4530); Physical Asymmetry (4573)

Event Date 07/19/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: roh yh, kang t, lim c, nam kw.Metal ion release according to leg length discrepancy in ceramic-on-metal hip arthroplasty.Acta ortop bras.2023 jun 9;31(spe2):e265272.Doi: 10.1590/1413-785220233102e265272.Pmid: 37323157; pmcid: pmc10263412.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.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.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: roh yh, kang t, lim c, nam kw.Metal ion release according to leg length discrepancy in ceramic-on-metal hip arthroplasty.Acta ortop bras.2023 jun 9;31(spe2):e265272.Doi: 10.1590/1413-785220233102e265272.Pmid: 37323157; pmcid: pmc10263412.Objective and methods: authors studied the impact of using ceramic on metal (com) bearing surfaces versus ceramic on ceramic (coc) bearing surfaces for hip replacements.In addition, authors also correlated the impact of leg length discrepancy (lld) and serum metal ion generation for the com group, broken into subgroups a and b, with a being <1 cm lld and b being >1 cm lld.A retrospective review of 173 primary total hip arthroplasties (tha) occurred with follow-up for at least 3 years, broken into group 1 with 114 com bearings and group 2 with 59 coc bearings.Of the group 1 hips, 48 were classified as 1-a, with lld <1 cm, and 30 hips classified as 1-b, with lld >1 cm.All thas received depuy ingrowth pinnacle acetabular cups, and depuy ingrowth summit femoral stems.Depuy biolox delta ceramic femoral heads were used for all patients.The group 1 thas all had depuy pinnacle ultamet metal acetabular liners implanted, while the group 2 thas were implanted with depuy biolox delta ceramic acetabular liners.Results: authors discovered that clinical outcomes for pain, stiffness, function, and results of womac survey scores were statistically not significant.Implant noise/squeaking occurred in 15 cases in group 1, and in 6 cases in group 2.There was no statistical difference in friction incidence between the two groups.There were significant positive correlations between lld and serum cobalt (co) and chromium (cr) levels.Although elevated, none of the patients in either group achieved toxic metal ion levels >7.0 ug/l.There were 2 patients in group 1, with lld of 18.7 mm and 14.3 mm respectively, who experienced adverse local reactions to metal debris (armd), with metal liner wear.They were both treated for pain and armd with hip revision surgery, with replacement of the bearing surfaces to ceramic on ceramic.Another case involved a periprosthetic bone fracture of the greater trochanter, treated with orif.Another patient was treated for postoperative wound infections, treated with wound irrigation and debridement.Complications: 2 cases: stem subsidence w/ lld, armd and pain, treated with revision of metal liner and head to coc.1 case: greater trochanter bone fracture, treated with orif.1 case: wound infection, treated with irrigation and debridement & bearing exchange.

• Brand Name: UNK HIP FEMORAL STEM SUMMIT
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18083863
• MDR Text Key: 327520831
• Report Number: 1818910-2023-22719
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/07/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM SUMMIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/07/2023
• 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