MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 28ID X 48OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121883748

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 07/08/2020

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 (b)(6): patient was admitted to hospital with a broken ceramic inlay in her left hip.A cup and head change on the left hip was carried out on (b)(6) 2020.Initial implantation took place ex domo on (b)(6) 2017.On (b)(6) 2019 an inlay was changed because of a fractured ceramic inlay in the hospital that carried out the initial implantation.A ceramic inlay was used again.A fall event cannot be remembered.A few weeks before the current surgery the patient noticed grinding and cracking noises.In diagnostics, another fracture of the ceramic inlay was obvious which was confirmed intraoperatively.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.X-ray images were reviewed and confirmed the ceramic liner had pieces broken off.A review of the device manufacturing records found no related deviations or anomalies.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.

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 : visual examination of the returned device confirms the reported material fracture.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.Device history lot : the quality documents show that the data obtained on the insert conformed to the specification valid at the time of production.

• Brand Name: DELTA CER INSERT 28ID X 48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10447881
• MDR Text Key: 204186930
• Report Number: 1818910-2020-18673
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 121883748
• Device Lot Number: 9065196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 28MM +5; DELTA CER HEAD 12/14 28MM +5; HIP ACETABULAR CUP; PINNACLE SECTOR II CUP 48MM; DELTA CER HEAD 12/14 28MM +5; HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR