MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Model Number	1218-87-658
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Fractured ceramic liner after 1 year of implantation.The surgeon would like the liner analysed by depuy for any reason this may have occurred.He has looked at immediate post-op xrays and can see the ceramic liner is not fully seated.It went on to fracture.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = visual examination of the returned device and photos confirmed the reported material fracture.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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.Device history lot = the density of the insert was analyzed and found to meet valid specifications at time of production.The microstructures as obtained from the quality documents meet the requirements as specified at time of production.No indications of pre-existing material defects were identified.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10698042
• Report Number: 1818910-2020-22744
• Device Sequence Number: 3709260
• Product Code: MRA
• UDI-Device Identifier: 10603295012542
• UDI-Public: 10603295012542
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1218-87-658
• Device Catalogue Number: 121881752
• Device Lot Number: 8844934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/04/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 02/18/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 10/29/2020; 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL2 LAT COXA VARA SIZE 11; DELTA CER HEAD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR HA ACET CUP 52MM; PINN SECTOR W/GRIPTION 52MM
• Outcome Attributed to Adverse Event: Required Intervention