MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 13.5MM; FEMORAL STEM

Catalog Number 155402135

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Limb Fracture (4518); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 07/11/2022

Event Type  Injury  

Event Description

Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning, injury to muscle and tissue, suffered additional scar tissue formation and now has a hip replacement with decreased longevity.Moreover.Suffered injuries, including but not limited to significant pain, injury caused by metallosis, metal wear, loss of enjoyment of life and limitation of daily activities.Patient incurred medical expenses and expects to incur additional expenses in the future.Additionally, has sustained emotional trauma and distress, mental anguish and economic losses.Doi: (b)(6) 2006.Doe/dor: (b)(6) 2022.Unk affected side (hip).

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.During follow up communication, the nurse stated that there has been no occurrence of health damage or complaints.Currently, cystoscopy has been discontinued and is not in use, and the washing machine is also not in operation.They are consistent by conducting inspections and filter replacement study sessions when inspections are resumed.Since it is not in operation, there is no health hazard, and no blood test is scheduled.The product to be cleaned during operation is a non-olympus product and the model number and device information was unknown.The facility does not own any endoscope products in-house, and do not plan to submit a scope for suspected reprocessing defects.The event may be prevented by following the instructions for use (ifu) and oer-6 instruction manual operation (revised number 2) at the time of shipment of the product regarding the replacement of the water filter, section 7.3 replacing the water filter (maj-2317).Olympus will continue to monitor field performance for this device.

Event Description

Pinnacle mom medical record received.Medical records report closed reduction dislocation on (b)(6) 2022.Affected side: left hip.

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.H6 clinical symptoms code: metal related pathology (e1618) used to capture metal poisoning and blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2022, an operative note of a femur fracture was treated with wires.The stem was retained.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: updated on 20 oct 2023.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.If additional information is made available, the investigation will be updated as applicable.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 evaluation (mre) was not performed.H10 additional narrative: added: b5, b7, d10, g4, h4 and h6 (clinical code) a1, d1, d2, d4, d6b and h6 (impact code) the previous reported date of explant in the stem is being retracted since it was not revised.

• Brand Name: AML LG STATURE 13.5MM
• Type of Device: FEMORAL STEM
• 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 46581-0988 ; 3035526892
• MDR Report Key: 16086586
• MDR Text Key: 306530493
• Report Number: 1818910-2023-00077
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295058366
• UDI-Public: 10603295058366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012364
• 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
• Report Date: 01/03/2023

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: 03/15/2011
• Device Catalogue Number: 155402135
• Device Lot Number: AJ3GX1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 08/21/2023; 10/20/2023
• Supplement Dates FDA Received: 08/31/2023; 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2006
• 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: AML LG STATURE 13.5MM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM SROM
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 75 KG