MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-310

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

Patient Problems Abscess (1690); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/26/2020

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

It was reported that the patient had a total hip replacement two weeks ago.Dr.(b)(6) received a call from the rehab center in regards to the wound.After examining the patient he determined the wound appeared to be oozing serosanguineous fluid and possibly pus.He decided to take the patient back to surgery for a washout and debridement.He mentioned there might be a small chance of swapping out the articulating components.Upon taking the patient back to surgery, initial swabs and fluid were sent back to pathology for a gram stain: a stat white cell count per high powered field was ordered.While waiting for the pathology report, he decided to go ahead and swap out the articulating components even though there was no evidence of compromise.He mentioned he would do this to be sure he took the proper steps to prevent any further spread of infection.The old components were removed safely and new components were put in after thorough debridement.Pathology only showed 1 white cell per high powered field.Doi: two weeks ago; dor: (b)(6) 2020; affected side: left hip.

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: b5.Removed patient harm infection as specified from the receipt of additional information that there was no evident presence of gross infection.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received states that the doctor specified there was no evident presence of gross infection.He believed it was strictly superficial but decided not to take any risks and swapped out the poly/femoral head.The labs also confirmed minimal white cells per high powered field.

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: DELTA CER HEAD 12/14 32MM +1
• 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
• MDR Report Key: 11132047
• MDR Text Key: 225539432
• Report Number: 1818910-2021-00619
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1365-32-310
• Device Catalogue Number: 136532310
• Device Lot Number: 9620878
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/01/2021; 02/08/2021
• Supplement Dates FDA Received: 01/11/2021; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX54OD; ALTRX NEUT 32IDX54OD
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR