MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 01/01/2023

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: yun hh, lee ws, shin yb, yoon th.Periprosthetic occult femoral fracture: an unknown side effect of press-fit fixation in primary cementless total hip arthroplasty.Hip pelvis.2023 jun;35(2):88-98.Doi: 10.5371/hp.2023.35.2.88.Epub 2023 jun 2.Pmid: 37323549; pmcid: pmc10264232.Objective and methods: the objectives of this study were to examine the prevalence and risk factors for development of periprosthetic occult femoral fractures during primary cementless total hip arthroplasty (tha) and to assess the clinical consequences of these fractures.A total of 199 hips implanted between (b)(6) 2012 and (b)(6) 2019 were examined.All patients received a cementless depuy corail or trilock femoral stem.The manufacturer of the femoral heads is unknown but assumed to be depuy.The manufacturer of the acetabular devices is unknown therefore excluded from the complaint.Periprosthetic occult femoral fractures were defined as fractures not detected intraoperatively and on postoperative radiographs, but only observed on postoperative computed tomography (ct).Clinical, surgical, and radiographic analysis of variables was performed for identification of risk factors for periprosthetic occult femoral fractures.A comparison of stem subsidence, stem alignment, and thigh pain between the occult fracture group and the non-fracture group was also performed.In the fracture group, the intraoperative ppfs were treated with cerclage and the occult ppfs, identified on post-op ct scan, were treated with weight bearing.The authors did not always specify treatment.This complaint will capture the group and patient specific results for both the fracture and non-fracture groups based on the information provided.Non-patient specific results: 14 reports of thigh pain: 13 in the non-fracture group and 14 in the fracture group.No treatments were provided and the authors noted the non-fracture reports of thigh pain were resolved within three months of primary implantation.The authors note that there were 14 patients within the fracture group who experienced thigh pain but did not specify which patients within the results chart.The pain code will only be added to the patient with known, identified thigh pain.The remaining will be captured in the non-patient specific results with a quantity of 1 and follow-up will be conducted.An unknown number stem subsidence noted in the non-fracture group.No treatment provided.Patient specific results: pt1: 63- year-old female patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 2: 65- year-old female patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 3: 66-year-old female patient corail stem sustained intraoperative ppff treated with a cerclage wire.No further treatment noted during follow-up.Pt 4: 72- year-old female patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 5: 65- year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 6: 71-year-old male with a trilock femoral stem sustained an intraoperative ppff treated with cerclage.No further treatment was needed during the follow-up period.Pt 7: 67-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 8: 67-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 9: 71-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 10: 75-year-old female patient corail stem sustained intraoperative ppff treated with a cerclage wire.The stem was revised one year later to fully treat the displaced fracture and associated thigh pain.Pt 11: 78-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 12: 63-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 13: 72-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 14: 69-year-old female patient corail stem sustained intraoperative ppff.Treated with weight-bearing and resolution within a month.Pt 15: 47-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 16: 71-year-old male patient with unk depuy femoral stem with a ct identified ppff treated with cerclage.Pt 17: 71-year-old male patient with unk depuy femoral stem with a ct identified ppff treated with cerclage.Pt 18: 70-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 19: 72-year-old male patient with a trilock femoral stem sustained an intraoperative ppff identified on post-op ct, treated with weight-bearing.Post-operative serial radiographic imaging identified femoral head subluxation and subsidence of the stem secondary to worsening of the ppff, which was treated with stem and head revision one year after primary.Thigh pain was reported.

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: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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: 18993154
• MDR Text Key: 338887354
• Report Number: 1818910-2024-06942
• 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
• Type of Report: Initial,Followup

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 HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/07/2024
• Supplement Dates FDA Received: 04/09/2024
• 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