MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 28MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-28-310

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

Patient Problems Fall (1848); Fatigue (1849); Pain (1994); Joint Laxity (4526)

Event Date 03/06/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the patient had a revision left hip with removal of acetabular cup, screws x5, and placement of competitor cup and screws x4, along with depuy femoral head.Prior to surgery, the patient was experiencing instability.During the procedure, the surgeon observed weakness of the gluteus maximus muscle.The dual mobility head was revised, along with the liner.Doi: (b)(6) 2022; dor: (b)(6) 2023; left hip.

Manufacturer Narrative

Product complaint # (b)(6).E3 initial reporter occupation: (b)(4).Follow-up is being conducted to obtain legal contact information.If/when the contact information is received, a supplemental med watch report will be submitted.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.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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(6) 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.

Event Description

Medical records were received: doe: (b)(6)2022: patient presents with pain and feelings of instability in her left hip.X rays identify a well-fixed and stable tha.Patient is treated with physical therapy and oral medication.Doe (b)(6)2022: patient received a closed reduction of the left hip to treat a dislocation after a slip and fall while feeding her cat.The procedure was completed without complications.The patient is prescribed additional physical therapy.Patient continued to experience pain and instability after physical therapy and on (b)(6)2023, the patient was referred for revision to treat the instability and pain secondary to dislocation of the left hip following a fall.(b)(6)2023: patient received a left hip revision to treat instability and pain secondary to a dislocation after a fall.The femoral stem was stable and retained.The cup, screws, and dual mobility head/liner were revised and replaced with competitor products.The procedure was completed without complications.The dislocation treated with closed reduction and the revision to treat instability are continuations of the same event.Doi: (b)(6)2023.Doe: (b)(6)2022.Dor: (b)(6)2023.Left hip.

• Brand Name: DELTA CER HEAD 12/14 28MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17266395
• MDR Text Key: 318488169
• Report Number: 1818910-2023-13636
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

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 Model Number: 1365-28-310
• Device Catalogue Number: 136528310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/07/2023; 07/27/2023
• Supplement Dates FDA Received: 07/25/2023; 07/28/2023
• 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: BI MENTUM PFRK PE LINER 28 53; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX50MM; PINNACLE DM LINER 62_53; UNKNOWN HIP ACETABULAR CUP; UNKNOWN SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female