MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +9; HIP FEMORAL HEAD

Catalog Number 136532330

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

Patient Problems Pain (1994); Discomfort (2330); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/19/2020

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

Surgeon reported to nca (bfarm): "hip-tep left side on (b)(6) 2013 in our hospital.Since (b)(6) 2020, after a rotational movement while working in the garden, patient was experiencing increasing pain and discomfort in the left hip joint.After this, he experienced squeaking noises in the left joint plus functional restrictments and pain under load.Hip-tep right side in 3/2007; content with this one.The x-ray examination indicated a dislocated inlay of the hip-tep on the left.Revision of left hip-tep on (b)(6) 2020.".

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.

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.Corrected: (patient,device).By removing joint code (dislocation).

Event Description

On (b)(6) 2020 the patient was revised for left hip tilted, dislocated cup insert (disassociation).The liner and cup was revised.Cup insert appears tilted and rotated, now opening in a lateral direction, resulting in impingement of the head at the lateral acetabular margin.

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: d1, d2a, d4 (catalog, udi), d10 (concomitant med products), h5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1 physical manufacturer.

• Brand Name: DELTA CER HEAD 12/14 32MM +9
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10808927
• MDR Text Key: 215298311
• Report Number: 1818910-2020-24168
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/22/2020

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 Catalogue Number: 136532330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 11/23/2020; 12/01/2020; 12/14/2020; 01/15/2021
• Supplement Dates FDA Received: 11/30/2020; 12/15/2020; 12/21/2020; 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP.; CORAIL2 STD SIZE 13.; PINN MAR NEUT 32IDX62OD.; PINNACLE 100 ACET CUP 62MM.; PINN MAR NEUT 32IDX62OD
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR