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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Impaired Healing (2378)

Event Date 09/27/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: xiao q, ling t, zhou k, yuan m, xu b, zhou z.Constrained acetabular liners are a viable option in second-stage re-implantation for chronic infected total hip arthroplasty with abductor or greater trochanter deficiency and large acetabular bone defects.Bmc musculoskelet disord.2022 oct 14;23(1):915.Doi: 10.1186/s12891-022-05861-1.Pmid: 36242038; pmcid: pmc9563789.Objective and methods: authors study the use of constrained acetabular liners (cals) for treatment of abductor mechanism deficiency in instances where the patients also present with large acetabular bone defects¿which are considered relative contraindications to cals.They specifically report the results of using cals in special cases in which abductor or greater trochanter deficiency was accompanied by large acetabular bone defects at second-stage re-implantation for chronic infected total hip arthroplasty (tha).19 patients who were treated with cals at second-stage re-implantation, and had abductor or greater trochanter deficiency and large acetabular bone defects were included in this study.These patients were followed up for clinical and radiological results.Complications and infection-related information were also noted.The depuy pinnacle esc constrained liner system was used in all 19 patients.Seventeen patients received depuy solution femoral stems, and 2 patients received depuy corail femoral stems.All patients used multihole cups to allow for multidirectional screws to supplement fixation.Authors did not provide any information with respect to models or manufacturers of primary implants that were explanted at the first stage of revision for infection.Although authors did provide specific patient case numbers, with age and gender demographics for the study participants, they did not provide any links to the reported complications with the specific patient cases or demographics.Results: after the second-stage re-implantation, one patient had the same positive synovial fluid culture result as the first stage (staphylococcus epidermidis).This patient was treated with intravenous sensitive antibiotics for 6 weeks after surgery and was free from recurrence of infection at the last follow-up.One patient suffered transient sciatic nerve palsy and fully recovered at 3 months after surgery.Two other patients had fatty fluidization of the incision, and the wounds healed after several dressing changes.Two patients presented acetabular radiolucent lines in one zone (zone 3) and 1 patient presented in two zones (zone 2 and 3) with no progression of lines at final follow-up.The implants of all patients remained stable at the last follow-up.Furthermore, no dislocation or failure of the cals occurred.Conclusion: authors concluded that for screened patients, cals are a viable option in second-stage re-implantation for chronic infected tha with abductor or greater trochanter deficiency and large bone defects.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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.

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 STEM
• Type of Device: HIP 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18476738
• MDR Text Key: 332491655
• Report Number: 1818910-2024-00659
• 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,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• 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