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

Model Number 1365-36-310

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

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

Surgeon was putting the final head onto the femoral stem and notified a black mark on the underside of the implant.It had come out of the box like this.He wasn¿t happy to impact it on so exchanged it for another head.See pic attached.Inner black marks are from when the implant was put on the taper but not impacted.I will return the item once i get it from (b)(6).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event of black markings.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a review was completed of the device history record (dhr) and operations management system (oms) for the following: product code 136536310, work order (b)(4) was issued on 18-oct-2019.(b)(4) parts were cleaned and packed to specification.There was no scrap associated with this lot.There were no non-conformances associated with this lot.There were no deviations associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.

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.

• Brand Name: DELTA CER HEAD 12/14 36MM +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
• MDR Report Key: 10962385
• MDR Text Key: 220213512
• Report Number: 1818910-2020-26400
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-36-310
• Device Catalogue Number: 136536310
• Device Lot Number: 9305484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 04/09/2021; 06/30/2021
• Supplement Dates FDA Received: 04/22/2021; 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1