MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 50OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882750

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2020, the patient was then subjected to a cat at lower limb-left hip which showed "thin labral resorption of the periprosthetic bone at the acetabular level.Diffuse reduction of calcium tone in correspondence of the skeletal segments".This was also confirmed by the scintigraphy of (b)(6) 2021.The examiners highlighted a break in the components of the prosthesis applied during the intervention of (b)(6) 2015 which justified the noises and severe pains accused by the patient.On (b)(6) 2021, patient was revised in (b)(6) with a diagnosis of "left hip joint rupture" and therefore the following day ( (b)(6) 2021) was subjected to "very urgent" surgery of "cup, insert and prosthetic head revision".Ad (b)(6) 2021: patient was revised to address discomfort, soreness, and implant fracture or broken/cracked or chipped.It was stated that this claim is not actively litigated.Ad (b)(6) 2021: the only related information available is that revision was performed due to a fracture of the ceramic insert, unrelated to a traumatic event.Doi: (b)(6) 2015; dor: (b)(6) 2021; (left hip).

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.H6 medical device problem code: appropriate term/code not available (a27) used to capture incident.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.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 insert is part of shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert conformed to the specification valid at the time of production.The component properties and microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.

Event Description

Pinnacle claim received.Claimant alleges constant pain and functional limitation post implantation.Claimant was revised due to fracture of the arthro-prothesis component.Claimant is seeking compensatory damages allege device related.

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.

• Brand Name: DELTA CER INSERT 32ID X 50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12307968
• MDR Text Key: 266037129
• Report Number: 1818910-2021-17597
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121882750
• Device Lot Number: 8077927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 32MM +9; DELTA CER INSERT 32ID X 50OD; PINNACLE SECTOR II CUP 50MM; TRI-LOCK BPS SZ 5 STD OFFSET; DELTA CER HEAD 12/14 32MM +9; DELTA CER INSERT 32ID X 50OD; PINNACLE SECTOR II CUP 50MM; TRI-LOCK BPS SZ 5 STD OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male