MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-320

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

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

Event Date 08/03/2020

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

Revision thr - it was reported that there was squeaking.

Event Description

What is the affected side involved in this event? answer: right.Was there any indication of loosening or breakage? what was the squeaking sound for? answer: previous dislocation.Can you please clarify if the patient experience any adverse symptoms that led to revision? please provide details.Answer: leg length discrepancy, squeaking - additional head length given to address issus from +5 to +9.

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.No code available (3191) is used to capture limb asymmetry.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the provided image could not confirm the reported allegations.The root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis 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.

• Brand Name: DELTA CER HEAD 12/14 32MM +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: 10494130
• MDR Text Key: 205674370
• Report Number: 1818910-2020-19492
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: 10603295033448
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-320
• Device Catalogue Number: 136532320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER INSERT 32ID X 50OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM; DELTA CER INSERT 32ID X 50OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM