MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-51-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hypoesthesia (2352); Joint Dislocation (2374); No Code Available (3191)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical adverse event received for posterior hip dislocation - initial.Event is serious and is considered moderate.Event is definitely related to both device and is possibly related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (left hip).Treatment: closed reduction.

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.H6 patient code: no code available (3191) used to capture the joint instability.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 reviewed.Patient underwent a revision on (b)(6) 2020 for recurrent instability and the head and liner were exchanged.The operative noted the stem was noted to be well fixed and in the correct version.The cup was also noted to be well fixed.

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.H10 additional narrative: added: h6 (patient).Corrected: h6 (patient/ no code available) from surgical intervention to device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2020, the patient had a closed reduction of left total hip arthroplasty to address dislocated left hip.The patient also reported feeling some numbness in the left lower extremity.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Examination of provided x-ray images finds the patient has had bi-lateral total hip replacement.This report involves the left hip.One image does depict a dislocation event.The devices appear well positioned.A root cause for the dislocation event cannot be determined.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.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : update 24mar2021.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: ARTICULEZE M HEAD 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10593249
• MDR Text Key: 208766483
• Report Number: 1818910-2020-20991
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/15/2020

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 Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 9475179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 10/30/2020; 11/03/2020; 03/24/2021
• Supplement Dates FDA Received: 10/18/2020; 10/30/2020; 11/17/2020; 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 36IDX52OD; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ6 HI OFF; ALTRX +4 NEUT 36IDX52OD; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ6 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 88