MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC 300 SERIES 46MM OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Catalog Number 124646000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Discomfort (2330); Physical Asymmetry (4573)

Event Date 09/02/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.

Event Description

It was reported that on (b)(6) 2011, the patient underwent the surgery via tha for right hip with implants in question.The surgery was completed successfully without any surgical delay.After the surgery, the patient consulted a doctor on (b)(6) 2022, about symptoms such as right hip discomfort and right knee collapse.A revision surgery was performed on (b)(6) 2022.Extractors by zimmer biomet were used to remove the cup, resulting in minimal bone loss.The cup was replaced to g7 produced by zimmer biomet, the hooded liner increased the head diameter to 36 mm, the head was extended to +3 mm, and the stem that was implanted on (b)(6) 2011, has been left.No defect such as tranionosis was seen in the removed implants, and the poly liner was slightly worn only.The patient has been paralyzed as a sequela of infantile paralysis on the left side and conducts activities of daily living with weight applied only to the right side.There is a considerable difference in leg length between left and right.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DURALOC 300 SERIES 46MM OD
• Type of Device: DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
• 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: 15649487
• MDR Text Key: 302168401
• Report Number: 1818910-2022-21043
• 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
• Report Date: 10/21/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 124646000
• Device Lot Number: 3041549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 9/10 COCR HEAD 22.225MM -3; AML A PLUS 14.0 MM; APEX HOLE ELIM POSITIVE STOP; CB DURALOC 10DEG LINER 46MM; DURALOC 300 SERIES 46MM OD
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female