MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Joint Laxity (4526)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.

Event Description

On (b)(6) 2011, the patient had a right hip arthroplasty to address post traumatic arthritis, right hip.The patient had a history of a traumatic hip injury previously.The patient was implanted with depuy components during this procedure.These implants included a metal insert and ceramic femoral head along with pinnacle shell and summit stem.On (b)(6) 2019, the patient had a revision right total hip replacement to address chronic groin pain with metallosis and impingement.During the procedure, the surgeon observed metallosis, the cup was at approximately 10 degrees of anteversion, therefore the shell was removed.The stem was noted to be well fixed with appropriate amount of anteversion and retained.A competitor shell dual mobility ceramic / polyethylene ball construct was implanted.On (b)(6) 2020, the patient had a complex revision right total hip arthroplasty, radical resection of scar, to address right hip aseptic loosening.Prior to surgery, the patient reported having pain, debilitating hip arthrosis, impaired daily function.Competitor shell, dual mobility liner, and depuy femoral head were revised.Depuy pinnacle cementless cup was implanted along with cross-linked polyethylene liner.*it should be noted that the surgical records provided for (b)(6) 2020 were not the correct surgery records as the patient was clearly having a revision as per the indications and the post operative pathology reports, but the surgical notes were for a primary.We will take the preoperative note and the pathology notes as being accurate as they more likely the correct records as the patient clearly had two previous surgeries on that hip.Medical history included: hypertension, hyperlipidemia, gastroesophageal reflux disease, depression, and sleep disorder.Doi: (b)(6) 2011; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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).A records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA CER HEAD 12/14 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18720775
• MDR Text Key: 335578574
• Report Number: 1818910-2024-03513
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2016
• Device Catalogue Number: 136536310
• Device Lot Number: 3256712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2011
• 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: PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT DUOFIX TAP SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male