MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136532310

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that the patient received a right hip liner and head revision to treat noise in the hip.The medical records identifying that the poly liner and ceramic femoral head were revised and replaced with a depuy altrx liner and metal femoral head.Doi: (b)(6) 2017; dor: (b)(6) 2023; right hip.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.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

Additional information received; a.What is the affected side involved in this event? left or right? right.B.What is the event date? no accident/trauma.C.Was there a surgical delay? if yes, what is the duration of the delay? no delay.D.Was there any patient harm relevant to this event? if yes, please kindly provide the details.No harm; female patient noticed a grinding noise in her hip joint, no pain.

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.H10 additional narrative: added: a3, b5 and d9.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 - it was reported that the sales rep reported: he has removed a pinnacle inlay, which was completely run after cranial.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the delta cer head 12/14 32mm +1 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.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A dimensional inspection was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the liner would contribute to the complained device issue.¿ based on the investigation findings, the potential cause is traced to component failure 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 reported 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 description: delta cer head 12/14 32mm +1 product code: 136532310.Lot number: 8550034 1) quantity manufactured: 20 parts 2) date of manufacture: (b)(6) 2017 3) any anomalies or deviations identified in dhr: there were no-non conformances associated whit this lot 4) expiry date: 31-may-2022 5) ifu reference: (b)(4).

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: doi: (b)(6) 2017: patient received a right pinnacle/corail tka including the pinnacle cup with apex hole eliminator, ceramix femoral head, altrx liner, and corail stem.Dor: (b)(6) 2023: patient received a right hip liner and head revision to treat noise in the hip.The medical records do not detail the procedure other than identifying that the poly liner and ceramic femoral head were revised and replaced with a depuy altrx liner and metal femoral head.There is no indication that the femoral stem or acetabular cup were revised.Additionally, there is no indication of wear for the poly liner.Aei note a-10546724 confirms that there were no patient harms associated with the noise from the hip.Doi: (b)(6) 2017.Dor: (b)(6) 2023.Right hip.

Event Description

Additional information was received: these are the components which were implanted during primary surgery: pinnacle cup 100er serie gr 50 lot 8589341, ref (b)(4).Pinnacle altrx pe actebular liner neutral 50/32 lot ha4266, ref (b)(4).Apex hohle eliminator - ps lot d17084123, ref (b)(4).Corail hip system cementless femoral stem, lot 5296379, ref (b)(4).Biolox delta ceramic femoral head, lot 8550034, ref (b)(4).During revision head and inlay were removed.These are the components wich were inserted during revision: pinnacle altrx pe actebular liner neutral 50/32, chargennr m39z85, udi (b)(4), ref (b)(4).Metal head 32 +5 mm konus 12/14, chargennr d22102065, udi (b)(4), lot 1365-22000.

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 HEAD 12/14 32MM +1
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18768427
• MDR Text Key: 336120777
• Report Number: 1818910-2024-04192
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031803
• 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,Followup,Followup
• Report Date: 02/23/2024

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: 05/31/2022
• Device Catalogue Number: 136532310
• Device Lot Number: 8550034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 03/14/2024; 03/08/2024; 04/04/2024
• Supplement Dates FDA Received: 03/12/2024; 03/19/2024; 03/22/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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 32IDX50OD; ALTRX NEUT 32IDX50OD; ALTRX NEUT 32IDX50OD; ALTRX NEUT 32IDX50OD; APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +5 BR; ARTICUL/EZE BALL 32 +5 BR; CORAIL2 STD SIZE 11; CORAIL2 STD SIZE 11; DELTA CER HEAD 12/14 32MM +1; PINNACLE 100 ACET CUP 50MM; PINNACLE 100 ACET CUP 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female