MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 18X12X135 36; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900534210

Device Problem Degraded (1153)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Joint Laxity (4526)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2013, the patient underwent the primary surgery via tha for oa for the right hip joint with the implants in question.The surgeon informed the sales rep that the patient had been hospitalized since late last year due to an anterior dislocation.The surgeon performed an mri scan, which confirmed the suspicion of trunnionosis.Revision surgery is scheduled for jan 17, 2024.In addition, the cup used for the primary surgery was a competitor's.No further information is available.

Manufacturer Narrative

Product complaint (b)(4).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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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

Additional information was received: revision surgery was performed on january 17th.The surgeon left the sleeve in the body without replacing it and replaced the stem with a "18x13 36+8lat" and the head with a "delta28-3." a "constraint liner" was used for the cup liner.Comments from the surgeons are as follows.Intraoperative findings at the time of revision revealed extensive gray tumor-like tissue around the hip, which was removed.The midline muscle was not attached to the greater trochanter and the joint was loose.The extraction implant (stem/head) was checked, and a black corrosion adhesion was observed at the joint.In contrast, no evidence of corrosion was observed at the stem/sleeve joint.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, it was reported that on (b)(6) 2013, the patient underwent the primary surgery via tha for oa for the right hip joint with the implants in question.The surgeon informed the sales rep that the patient had been hospitalized since late last year due to an anterior dislocation.The surgeon performed an mri scan, which confirmed the suspicion of trunnionosis.Revision surgery is scheduled for jan 17, 2024.In addition, the cup used for the primary surgery was a zimmerbiomet continuum.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The x-ray investigation does not reveal any damage to the device srom 9/10 18x12x135 36.No dislocation between the head and the liner is observed.With the information provided, it cannot be concluded that there is any type of corrosion in the implants.Therefore, the condition of the complaint cannot be confirmed.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the srom 9/10 18x12x135 36 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product code 900534210, work order (b)(4) srom 9/10 18x12x135 36 was manufactured on 28-feb-2012.06 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformance associated whit this lot.Ifu reference as per bill of material: 78410338 s-rom (a) ifu.

• Brand Name: SROM 9/10 18X12X135 36
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18579104
• MDR Text Key: 333724948
• Report Number: 1818910-2024-01729
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2017
• Device Catalogue Number: 900534210
• Device Lot Number: 3430146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/19/2024; 04/03/2024
• Supplement Dates FDA Received: 01/28/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2012
• 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
• Patient Sex: Female