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 Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Patient had corail pinnacle thr on [date].Patient was progressing well until 3 weeks post op.He then felt a grinding sensation.Presented back to surgeon at 6 weeks - x-ray showed that the liner may have disassociated from the shell.Revised on [date], liner was not locked into shell properly.Ceramic head had been articulating against the shell.Head & liner removed and replaced.Surgeon stated at original surgery he felt the liner was implanted and locked into shell as far as he could see.Experienced surgeon who has done many corail/pinnacle cup thr - has never had this happen in the past.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? yes, facility name of original implant [hospital], was device explanted? true, did patient require revision surgery? true, if yes, date of revision surgery.[date], reason for revision surgery.To replace liner and head - liner deformed and not locked into shell; head scratched due to articulating against shell instead of liner., patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? patient required revision surgery, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe patient required revision surgery to replace head & liner., is the patient part of a clinical study no, activity level active, ip-01916890, device property of none, device in possession of none, ip-01916891 device property of none, device in possession of none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : patient was progressing well until 3 weeks post op.He then felt a grinding sensation.Presented back to surgeon at 6 weeks - x-ray showed that the liner may have disassociated from the shell.Revised on [date], liner was not locked into shell properly.Ceramic head had been articulating against the shell.Head & liner removed and replaced.Surgeon stated at original surgery he felt the liner was implanted and locked into shell as far as he could see.Experienced surgeon who has done many corail/pinnacle cup thr - has never had this happen in the past.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo and x-ray investigation revealed that the delta cer head 12/14 36mm +1.5 presented a worn appearance due to material transfer as a result of a unintended interaction with the inner surface of the acetabular cup.Based on the observations, it is reasonable to conclude that audible sound would be present due to the unintended articulation of the head and the cup.Implant disassociation was not confirmed since the head was properly assembled with the femoral stem.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the delta cer head 12/14 36mm +1.5 may have been caused by exposure to irregularities in the weight loading of the device and moments generated.The event is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Product code 136536310, work order (b)(4) artic delta ceramic 36mm +1.5 was manufactured on 05-may-2023.20 parts were manufactured per specification and all raw materials met specification.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the delta cer head 12/14 36mm +1.5 would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product code 136536310, work order (b)(4) artic delta ceramic 36mm +1.5 was manufactured on 05-may-2023.20 parts were manufactured per specification and all raw materials met specification.Device history review : product code 136536310, work order (b)(4) artic delta ceramic 36mm +1.5 was manufactured on 05-may-2023.(b)(4) were manufactured per specification and all raw materials met specification.

• 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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18360178
• MDR Text Key: 330934557
• Report Number: 1818910-2023-25649
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136536310
• Device Lot Number: 4150768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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: ALTRX NEUT 36IDX54OD.; PINN SECTOR W/GRIPTION 54MM.; UNKNOWN HIP ACETABULAR CUP.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG