MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP PINNACL

Device Problem Corroded (1131)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Laxity (4526); Metal Related Pathology (4530); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 08/03/2022

Event Type  Injury  

Event Description

Pinnacle metal on metal medical records received.After review of the medical records the patient was revised to address metallosis, elevated metal ions and hip pain.Mri reported collection consistent of metallosis.Operative note reported rush of cloudy darkened fluid consistent with metal debris.There was evidence of corrosion in the synovial and whitish appearing fluid.Corrosion in the head, metal debris, length instability and leg length discrepancy, doi: (b)(6) 2009; dor: (b)(6) 2022; left hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.D4: the device catalog number is unknown; therefore, udi is unavailable.Investigation summary =an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the 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 or product id numbers are received at a later date, the investigation will be updated as applicable.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that pinnacle metal on metal medical records received.After review of the medical records the patient was revised to address metallosis, elevated metal ions and hip pain.Mri reported collection consistent of metallosis.Operative note reported rush of cloudy darkened fluid consistent with metal debris.There was evidence of corrosion in the synovial and whitish appearing fluid.Corrosion in the head, metal debris, length instability and leg length discrepancy, doi: (b)(6) 2009; dor: (b)(6) 2022; left hip.The photo was returned to depuy synthes for evaluation.(b)(4).Visual analysis of the provided x-ray evidence was not able to confirm the complaint since no signs of implant corrosion were observed.No other issues were identified.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 unconfirmed as the observed condition of the unk hip acetabular cup pinnacle would not contribute to the complained device issue.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 : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

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: a4, b6, b7 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 pinnacle metal on metal medical records received.After review of the medical records the patient was revised to address metallosis, elevated metal ions and hip pain.Mri reported collection consistent of metallosis.Operative note reported rush of cloudy darkened fluid consistent with metal debris.There was evidence of corrosion in the synovial and whitish appearing fluid.Corrosion in the head, metal debris, length instability and leg length discrepancy, doi: (b)(6) 2009; dor: (b)(6) 2022; left hip.The photo was returned to depuy synthes for evaluation.Attachments reviewed "(b)(4) _x-ray_images-received 28-sept-2023 and (b)(4) _x-ray_images-received 06-oct-2023".Visual analysis of the provided x-ray evidence was not able to confirm the complaint since no signs of implant corrosion were observed.No other issues were identified.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 unconfirmed as the observed condition of the unk hip acetabular cup pinnacle would not contribute to the complained device issue.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: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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: 17549102
• MDR Text Key: 321159801
• Report Number: 1818910-2023-16732
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: -2, 36 FEMORAL HEAD; 36 X 52 PINNACLE NEUTRAL METAL INSERT; HOLE ELIMINATOR,; SIZE 3 TRI LOCK FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 62 KG