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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/26/2022

Event Type  Injury  

Event Description

It was reported that on april 26, 2022, the patient underwent a tha surgery for oa of right hip with the stem and a competitor¿s cup.The surgery was completed with no surgical delay.Immediately after surgery, when an x-ray was checked, it was found that a dislocation occurred since the anteversion of the femoral stem was not appropriate.Hospital staff discussed whether to perform a revision surgery immediately or not, but it was decided to perform a revision surgery on another day because there was a lot of bleeding during a long operation (9 hours).The date of a revision surgery has not been decided yet.The surgeon commented as follows.This was the first time for the surgeon to use a srom.Although the surgeon had been fully briefed on the characteristics of the implant and the instruments for this surgery, the tha this time was a difficult surgery since a subtrochanteric osteotomy was also performed simultaneously.Therefore, the surgeon could not pay attention enough to the delicate control of stem anteversion.Another possible cause of the event was insufficient preoperative planning.Although the timing is unknown, the patient had a history of rotational acetabular osteotomy in both hips.The patient has no allergies or smoking history.No further information is available.

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.

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.Removed the device code off label use.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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: 14433750
• MDR Text Key: 292032431
• Report Number: 1818910-2022-09048
• 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: 05/18/2022

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 Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 05/19/2022; 05/30/2022
• Supplement Dates FDA Received: 05/20/2022; 05/31/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: COMPETITOR CUP; SROM 9/10 14X9X150 30; UNK HIP FEMORAL STEM SROM; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG