MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP BONE SCREW

Catalog Number UNK HIP BONE SCREW

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

Patient Problems Fever (1858); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Unspecified Tissue Injury (4559)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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

Pinnacle mom litigation records received.Litigation alleges revision due to heavy metal poisoning from toxic metals resulting to pain, pseudotumor, trunnionosis, tissue destruction, metal wear, loss of enjoyment of life, limited adl, emotional trauma and distress.Doi: (b)(6) 2006; dor: (b)(6) 2021; hip unknown.

Event Description

Medical records were received and stated the following: on (b)(6) 2021: incision and drainage of shoulder deep abscess and hematoma with left shoulder myolitis with incomplete collection.On (b)(6) 2021.Patient was revised due to right total hip arthroplasty painful metallosis with superimposed concern for periprosthetic infection.Also reported of cobalt poisoning.

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: 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 : no device associated with this report was received for examination.Review of the x-ray evidence found nothing indicative of a device nonconformance or a relation between the product and the reported event.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 record evaluation (mre), was not possible because the required lot code was not provided.

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: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Affected side: right hip.

• Brand Name: UNK HIP BONE SCREW
• Type of Device: BONE SCREW
• 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: 16530596
• MDR Text Key: 311206201
• Report Number: 1818910-2023-05693
• Device Sequence Number: 1
• Product Code: LPH
• 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,Followup
• Report Date: 03/13/2023

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 Catalogue Number: UNK HIP BONE SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/28/2023; 04/25/2023; 09/28/2023; 10/09/2023
• Supplement Dates FDA Received: 04/10/2023; 04/26/2023; 09/28/2023; 10/19/2023
• 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: SROM UNK HIP FEMORAL STEM SROM.; UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP ACETABULAR LINER METAL PINNACLE.; UNK HIP ACETABULAR LINER METAL PINNACLE.; UNK HIP BONE SCREW.; UNK HIP BONE SCREW.; UNK HIP BONE SCREW.; UNK HIP BONE SCREW.; UNK HIP FEMORAL HEAD METAL.; UNK HIP FEMORAL HEAD METAL.; UNK HIP FEMORAL SLEEVE SROM.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male