MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 1 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101214010

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Weakness (2145); Anxiety (2328); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544)

Event Date 12/10/2010

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Pinnacle litigation received.Litigation alleges pain, discomfort, weakness of the hip and inflammation in his bilateral thighs and groin.Patient also suffered from the release of large amounts of toxic cobalt-chromium in his blood and tissue and bone surrounding the implant.(b)(6) 2009: (b)(6) 2010 (left hip).

Event Description

In addition to what was previously reported, patient alleges consistent chronic pain, walking with limp and unable to jog or run.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.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).No device associated with this report was received for examination.

Event Description

After review of medical records for mdr reportability it was reported that the patient was revised to address elevated blood metal level, persistent and worsening pain.Patient has a history of anxiety and depression.Revision note reported that the left leg showed slightly longer than the right leg.There was a moderate amount of fluid in the hip joint but not appear to be infected.The femoral stem was found to be well ingrown and was not revised.

Manufacturer Narrative

Pc-(b)(4) no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.If information is obtained that was not available for the initial 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.Product complaint #
=
> (b)(4).Investigation summary
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> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.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.Udi: (b)(4).

• Brand Name: TRI-LOCK BPS SZ 1 HI OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7215044
• MDR Text Key: 98070201
• Report Number: 1818910-2018-51915
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/05/2018

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: 101214010
• Device Lot Number: CW3ALA000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 02/21/2018; 03/26/2018; 04/02/2018; 04/02/2018; 04/02/2018; 07/09/2018; 04/29/2019; 07/24/2019
• Supplement Dates FDA Received: 02/21/2018; 04/04/2018; 04/13/2018; 04/20/2018; 04/23/2018; 07/16/2018; 05/16/2019; 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 76