MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR POLY/METAL HEMI

Catalog Number UNK HIP ACETABULAR POLY/METAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/15/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, the patient underwent the bipolar hip arthroplasty with the actis collared.The surgery was completed successfully without any surgical delay.After the surgery, dislocation occurred on (b)(6) 2022.Therefore, the total hip arthroplasty revision surgery will be performed on (b)(6) 2022.The stem will be removed, and anterior torsional adjustments will be made with implants from another company.The surgeon will use dual mobility.The cause of the dislocation is unknown.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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).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.

Event Description

A.Was the stem noted, to be mispositioned? the stem dislocation occurred, on (b)(6) 2022.1.Has the revision taken place? if so, when, and what was actually removed? on (b)(6) 2022, a revision surgery was performed.The stem was removed and replace to another company stem.2.Did the bipolar dislocate? no further information is available.3.Why was the stem to be removed, if it was a dislocation event? due to the revision from bha to tha.4.We understand, that anterior torsional adjustments will be made.Was there a positioning issue with actis stem? no further information is available.5.Which components dislocated? 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.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected h6: (patient).

• Brand Name: UNKNOWN HIP ACETABULAR POLY/METAL HEMI
• Type of Device: HIP ACETABULAR POLY/METAL HEMI
• 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: 15360831
• MDR Text Key: 299289321
• Report Number: 1818910-2022-17146
• Device Sequence Number: 1
• Product Code: LZY
• 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: 09/06/2022

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 ACETABULAR POLY/METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/07/2022; 09/13/2022
• Supplement Dates FDA Received: 09/12/2022; 09/13/2022
• 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: ACTIS COLLARED STD SIZE 4; UNKNOWN HIP ACETABULAR POLY/METAL HEMI; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention