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

Catalog Number UNK HIP STEM SROM

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

Patient Problems Nerve Damage (1979); Thrombosis/Thrombus (4440); Limb Fracture (4518)

Event Date 11/30/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: lan y, feng e, lin b, lu z, lin f, weng y.Direct anterior versus posteriorlateral approachs for clinical outcomes after total hip arthroplasty in the treatment of severe ddh.Bmc musculoskelet disord.2022 nov 5;23(1):958.Doi: 10.1186/s12891-022-05759-y.Erratum in: bmc musculoskelet disord.2022 nov 30;23(1):1034.Pmid: 36335347; pmcid: pmc9636645.Objective: the total hip arthroplasty (tha) has gained popularity in in the treatment of severe developmental dysplasia of the hip (ddh).The posterior lateral approach (pla) has good clinical efficacy and has been confirmed by the majority clinicians.Nevertheless, controversy exists regarding longer-term benefits of the direct anterior approach (daa).The objective of this study was to investigate the clinical efficacy and placement of s-rom prosthesis in the treatment of severe ddh by the total hip arthroplasty (tha) with different surgical approaches.Methods: a retrospective analysis was performed on 42 patients with severe ddh admitted to our hospital from august 2015 to february 2022, who were treated with s-rom femoral prosthesis, including the stem, sleeve, and femoral head, for total hip arthroplasty and subtrochanteric osteotomy of the femur.They were divided into daa group and pla group according to different surgical approaches.Perioperative indicators and imaging data were collected.The manufacturer of the acetabular components utilized were unknown.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: s-rom femoral prosthesis including the stem, sleeve, and femoral head adverse event(s) and provided interventions associated with depuy devices: 2 cases of distal femoral fracture during implantation- treatment unknown.3 cases of femoral nerve palsy treated with medication.The palsies were all resolved at 6 months.Unknown number of postoperative femoral dvt- treatment unknown.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.

Manufacturer Narrative

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 a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM SROM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17117204
• MDR Text Key: 317145244
• Report Number: 1818910-2023-12186
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/13/2023

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 STEM SROM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA 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