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

Catalog Number 900534210

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Scarring (2061); No Code Available (3191)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

(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

The primary surgery was performed on (b)(6) 2010 via tha for the patient¿s right hip joint.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the liner (p/n: 121887354), the head (p/n: 962713000) and the stem (p/n: 900534210) due to suspicion of infection.Before the surgery, the pseudotumor was not found by x-rays, and the surgeon had a difficulty in judging whether there was infection although there was rising crp level.There was no anthema and redness around the primary surgery¿s incision.During the revision surgery, the surgeon found that the head and the neck-junction of the stem were black discolored and surrounding tissue was covered with scarring tissue.The revision surgery was completed, and it was unknown whether there was any surgical delay.The surgeon commented that this result was as per reported mom case, and it was expected result in consideration of the patient¿s high activity, sex (male) and mom.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.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.H6 patient code: no code available (3191) is used to capture device revision or replacement.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.A complaint database search did find an additional related report against the provided product code and lot number combination(s).However; a review of the device history record identified no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Any additional information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Device history lot 2989432.Device history review
=
> no anomalies found.H10 additional narrative:.

• 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
• MDR Report Key: 10075008
• MDR Text Key: 191566504
• Report Number: 1818910-2020-12336
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2020

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 Catalogue Number: 900534210
• Device Lot Number: 2989432
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 06/04/2020; 07/13/2020
• Supplement Dates FDA Received: 06/08/2020; 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 36MM HEADS +6; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE-A SCREW 6.5X15; PINNACLE-A SCREW 6.5X30; 9/10 ULTAMET 36MM HEADS +6; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE-A SCREW 6.5X15; PINNACLE-A SCREW 6.5X30
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR