MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-320

Device Problems Difficult to Remove (1528); Inaccurate Information (4051); Wrong Label (4073)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the insert in question, cracked, leaving the head stuck without the patient making excessive efforts.When we received the implants, we checked them and we are trying to understand the number described in the head, because it is different from the lot identified in the external box and our traceability records.We would like to know if something different may have occurred in relation to this implant, in order to be identified differently than usual.

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.

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: 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: device associated with this report was not received for examination.All photographs were reviewed.Complaint cannot be confirmed.There is no evidence that the femoral was stuck with another implant.Additionally, the label with the number 4236646 is not a valid number for depuy, this is a number from the manufacturer.A worn appearance can be observed on the femoral head surface, this might be due to material transfer most likely caused by being in unintended direct contact with the acetabular cup.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the ceramic insert belongs to the shop order 7011279193.Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the 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.Device history review: a manufacturing record evaluation was performed for the finished device delta cer head 12/14 32mm +5(product code: 136532320, lot number: 8876494) number, and no non-conformances / manufacturing irregularities were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.The printed numeration on the edge of the femoral head corresponds to a lot number from the manufacturer.A worn appearance can be observed on the femoral head surface, this might be due to material transfer most likely caused by being in unintended direct contact with the acetabular cup.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : device associated with this report was not received for examination.All photographs were reviewed.Complaint cannot be confirmed.There is no evidence that the femoral was stuck with another implant.Additionally, the label with the number (is not a valid number for depuy, this is a number from the manufacturer.A worn appearance can be observed on the femoral head surface, this might be due to material transfer most likely caused by being in unintended direct contact with the acetabular cup.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the ceramic insert belongs to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the 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.Device history review : a manufacturing record evaluation was performed for the finished device delta cer head 12/14 32mm +5(product code: 136532320, lot number: 8876494) number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DELTA CER HEAD 12/14 32MM +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 46581-0988 ; 3035526892
• MDR Report Key: 15363190
• MDR Text Key: 305714548
• Report Number: 1818910-2022-17184
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: 10603295033448
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-320
• Device Catalogue Number: 136532320
• Device Lot Number: 8876494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 11/17/2022; 11/28/2022; 01/11/2023; 01/18/2023; 02/08/2023
• Supplement Dates FDA Received: 10/14/2022; 11/17/2022; 11/29/2022; 01/16/2023; 01/19/2023; 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• 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: PINN MAR +4 10D 32IDX50OD