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

Catalog Number UNK HIP FEMORAL STEM SROM

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 06/29/2022

Event Type  Injury  

Event Description

This (b)(4) is related to (b)(4).(b)(4) reports regarding the revision surgery which was performed after the primary surgery.This (b)(4) reports regarding skin rash which appeared after the revision surgery.It was reported that on (b)(6) 2013, the patient underwent the revision surgery with the head.The surgery was completed successfully without any surgical delay.On (b)(6) 2017, the accord cable got broke after the revision surgery on (b)(6) 2013.On (b)(6) 2022, the patient underwent the second surgery due to the pseudoarthrosis of the greater trochanteric femur, and the accord was removed.On (b)(6) 2021, the patient underwent the removal surgery of the foreign body in the femur.The second surgery and the removal surgery were not related to the depuy devices.Skin rash was found that appeared to be a metal allergy.The size of the stem was long, and it seemed to be difficult to remove.Therefore, the surgeon decided to replace the head with a new head.The revision surgery will be performed on (b)(6) 2022.The cup in question will be discarded.No further information is available.

Manufacturer Narrative

(b)(4) - (b)(6) 2022..Skin rash was found that appeared to be a metal allergy.On (b)(6) 2022, the revision surgery was performed.The metal head and the liner were replaced.The surgeon wanted to replace the stem; however, if he removes the stem, the femur will be broken.Therefore, the surgeon decided to leave the stem.Although the surgeon wanted to use a delta head with sleeve, there is no 9/10 delta head.The surgeon determined to use a delta head.The neck of the stem was blackened, so that the surgeon carefully polished the neck with a sterile brush.The removed head was blackened, and the surgeon assumed that it was armd.We got this info from the sales rep on june 30, 2022.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).No device associated with this report was received for examination.All photographs were reviewed.Based on the provided evidence, complaint cannot be confirmed.No signs of implant corrosion corrosion are visible on the photo attached.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• 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, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14958549
• MDR Text Key: 295510344
• Report Number: 1818910-2022-12671
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

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: UNK HIP FEMORAL STEM SROM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/02/2022
• 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
• Treatment: 9/10 COCR HEAD 32MM +0; UNK HIP FEMORAL SLEEVE SROM; UNK HIP FEMORAL STEM SROM
• Patient Outcome(s): Required Intervention