MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 28ID X 58OD; HIP IMPLANT CERAMIC ACETABULAR LINER

Catalog Number 121883758

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

Patient Problems Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/02/2021

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

Due to the appearance of luxation and squeaking, the patient goes for a revision, when surgeon opening the patient, the appearance of metallosis is seen due to which they had to remove the cup the new revision date was (b)(6) 2021 where all these components have been removed and new ones installed.Date of initial surgery(b)(6) 2006.Affected side-left.

Event Description

A.Was there any surgical delay? if yes please indicate the duration.B.Date of initial surgery-(b)(6) 2006.C.Affected side-left.D.Please clarify what squizing means.Noise sound in hip (squeaking).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

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).Investigation summary: update 14-jul-2021: the investigation was re-opened upon receipt of the device.Examination of the returned device could not confirm the reported event.Depuy considers the investigation closed.Should additional info be received, 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA CER INSERT 28ID X 58OD
• Type of Device: HIP IMPLANT CERAMIC ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11697484
• MDR Text Key: 246446901
• Report Number: 1818910-2021-08330
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 121883758
• Device Lot Number: 3217401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M 28MM 8.5.; SPIR SANDBLASTED CUP D58.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR