MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 16X11X130 30; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 900531210

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2021, the revision surgery was performed.In the revision, after the head was removed, the surgeon tried to remove the stem, but the stem couldn¿t be removed, and it was left in the patient.The competitor implants were set, and the surgery was completed with a 30 minute delay.The surgeon commented that the cold welding occurred between the stem and sleeve and the working space was narrow.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SROM 9/10 16X11X130 30
• 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): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11732089
• MDR Text Key: 247509064
• Report Number: 1818910-2021-08869
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900531210
• Device Lot Number: 7797527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 06/07/2021; 05/13/2022
• Supplement Dates FDA Received: 06/09/2021; 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM 9/10 16X11X130 30; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM 9/10 16X11X130 30
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG