MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK TI 15.0 STD OFFSET; HIP FEMORAL STEM/SLEEVE

Catalog Number 101211150

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address unknown reasons.Update 01/20/2017 claim letter and medical records received.After review of the medical records for mdr reportability, litigation alleges hip pain, elevated metal ion toxicity, soft tissue damage and an overall decline in health.Also alleges within the right hip, the presence of significant fluid collection and soft tissue injury by way of mri--but surgeon noted mri report indicated "no evidence of significant soft tissue injury or pseudotumor".Revising surgeon indicated, in office note on (b)(6) 2016, that metal ions are markedly elevated, with chromium 24 and cobalt 45 (no units reported).In the revision operative note, surgeon identified "black and darkened synovial tissue and avascular tissue consistent with metallosis".Also noted "corrosion.At the femoral head." also noted "that the acetabular component was.In slightly increased anteversion and abduction", and was revised.Pain, metallosis, elevated metal ions, corrosion, and malpositioned implant harms added to complaint.Stem is added to complaint (part/lot from invoice).The complaint was updated on: 1/27/2017.

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Depuy still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update (4/5/2017) - legal submission received.After review of this submission, there is no new information that would change the existing mdr decision.

Manufacturer Narrative

(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges metal wear/metallosis and elevated metal ions.

Event Description

Pfs alleges injuries, pain right hip, elevated metal ions, mri showed significant fluid collection and soft tissue injury and limited adl.Patient had sustained a permanent damage due to elevated metal ions in the system.After the first revision, there was continued chronic pain in the groin, hip and radiated to buttock and back.Ppf alleges metal wear, metallosis and elevated metal ions confirmed in the medical records.After review of the medical records, the patient was revised to address failed mom right tha resulting to pain, elevated metal ions and limited adl.Operative notes reported that the patient had black and darkened synovial tissue and avascular tissue consistent with metallosis.There was corrosion noted at the femoral head.Stem was well fixed.Acetabular was noted to have slightly increase anteversion and abduction and this was removed without difficulty.Right hip pericapsular tissue or pseudotumor.Doi: (b)(6) 2006 and dor: (b)(6) 2016 right hip.

Manufacturer Narrative

Product complaint # (b)(4).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.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.Udi (b)(4).H6 clinical code)appropriate term / code not available (e2402) is used to capture blood heavy metal increased.

• Brand Name: TRI-LOCK TI 15.0 STD OFFSET
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6289132
• MDR Text Key: 66121809
• Report Number: 1818910-2017-11588
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K872878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101211150
• Device Lot Number: ZS4E9B000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 79