MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 28MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136528310

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

Patient Problem Foreign Body Reaction (1868)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Patient was revised on (b)(6) 2022 for unknown reason, and later re-revised on (b)(6) 2023, where the head and insert were replaced due to metallosis.No surgical delay reported.

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.

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: a1 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 that 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.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.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 : description: 1.Surgery with novelty since reference cup implant * batch * is removed, acetabular screws length 20 ref * lot *, acetabular screw length 25 ref * lot *, reference insert * lot *, ceramic head reference * lot *, this patient has had several interventions the cup was placed on (date of implantation removed) and was re-operated where the insect and head are placed on the day (date of re-intervention) and today the reintervention is done again because the material generated metallosis and the decision is made to place the cemented cup and the disc insert and head 222,225 +7 johnson , the extracted material is left for study and delivered to the stock manager and the head of centra, photo evidence is sent.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 device found nothing indicative of a device nonconformance.However, metal transfer is observed.This condition is due to the dissociation between the liner and the cup, which caused the head to be in contact with the cup.However, no damage is observed on the ceramic head.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the delta cer head 12/14 28mm +1.5 would not contribute to the reported adverse event.Based on the investigation findings, 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 : a manufacturing records evaluation (mre) was not performed as no valid lot number was provided for this device.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, description: 1.Surgery with novelty since reference cup implant * batch * is removed, acetabular screws length 20 ref * lot *, acetabular screw length 25 ref * lot *, reference insert * lot *, ceramic head reference * lot *, this patient has had several interventions the cup was placed on (date of implantation removed) and was re-operated where the insect and head are placed on the day (date of re-intervention) and today the reintervention is done again because the material generated metallosis and the decision is made to place the cemented cup and the disc insert and head 222,225 +7 johnson , the extracted material is left for study and delivered to the stock manager and the head of centra, photo evidence is sent.¿ the product was not returned to depuy synthes, however photos were provided for review.See attachment sabana chía - 455735- de pérez - pt maría mery vargas pinzon.The photo investigation revealed nothing indicative of a device nonconformance.However, metal transfer is observed.This condition is due to the dissociation between the liner and the cup, which caused the head to be in contact with the cup.However, no damage is observed on the ceramic head.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the delta cer head 12/14 28mm +1.5 would not contribute to the reported adverse event.Based on the investigation findings, 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 : a manufacturing records evaluation (mre) was not performed as no valid lot number was provided for this device.

• Brand Name: DELTA CER HEAD 12/14 28MM +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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18637022
• MDR Text Key: 334492167
• Report Number: 1818910-2024-02286
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033271
• UDI-Public: 10603295033271
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup,Followup
• Report Date: 02/02/2024

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 Catalogue Number: 136528310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/03/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 02/13/2024; 04/04/2024; 04/24/2024; 04/25/2024
• Supplement Dates FDA Received: 02/06/2024; 02/15/2024; 04/05/2024; 04/25/2024; 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR +4 10D 28IDX46OD; PINNACLE BANTAM ACET CUP 46MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female