MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNK REAMER

Catalog Number UNK REAMER

Device Problems Break (1069); Entrapment of Device (1212); Device Contamination with Chemical or Other Material (2944)

Patient Problems Ossification (1428); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); No Code Available (3191); Paresthesia (4421); Unspecified Tissue Injury (4559)

Event Date 02/26/2014

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

Due to an osteonecrosis of the left femoral head, the patient was operated with a total left hip prosthesis.During the total left hip prosthesis surgery, a reamer broke and a metal fragment remained on the diaphysis patient.The patient had left cruralgia pain and right paresthesia.Consultation report determined that the pain was certainly linked to the contact between the fragment reamer remained on the patient and the prosthesis tail.This contact caused a metallosis.An osteotomy with a lcp plate occured to remove the fragment reamer which remained on the patient.

Manufacturer Narrative

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.Product complaint # (b)(4).No device was received.Root cause undetermined.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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.

Event Description

Additional information was received and reviewed: this record was already been examined in expertise at the request of the tribunal of reunion on (b)(6) 2019.In connection with the breakage of material during surgery, the notion of a therapeutic hazard.In connection with aseptic osteonecrosis, the patient suffered from his hip right since the end of 2012.The mri of (b)(6) 2013 confirms bilateral osteonecrosis of the femoral heads.Following the breakage of equipment, no materiovigilance declaration was made.This declaration is however compulsory according to article l.5212-2 of the code of the public health.It is therefore impossible to comment on whether or not the product is defective.This breach is the cause of a loss of opportunity for the patient to obtain full compensation for the damage resulting from the medical accident.You indicate that no reproach can be addressed to the surgeon in the performance of the gesture.It is therefore highly probable that the breakage of equipment is linked to a defect in the product, especially since doctor has already declared having experienced a similar difficulty shortly thereafter.

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 updated on 25 aug 2023 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.

• Brand Name: UNK REAMER
• Type of Device: REAMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8340399
• MDR Text Key: 136172774
• Report Number: 1818910-2019-84613
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK REAMER
• Device Lot Number: 2045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male