MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101214040

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Discomfort (2330); Joint Swelling (2356); Osteolysis (2377); Not Applicable (3189); No Code Available (3191)

Event Date 05/04/2015

Event Type  malfunction  

Manufacturer Narrative

Udi: unavailable.Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges that the patient suffers from pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.

Manufacturer Narrative

Conclusion and justification status for mdr: 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.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

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update 10/07/2016 - pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated metallosis, pain, and osteolysis.Lab results indicated metal ion levels above 7ppb.Part/lot is being updated.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the liner.Per procedure, this device is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Medical records need reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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

Pfs and medical records received.After review of the medical records for mdr reportability, it is determined that there is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2017.

Manufacturer Narrative

(b)(4)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.

Event Description

Complaint description: litigation alleges that the patient suffers from pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Update (b)(6)16-pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated metallosis, pain, and osteolysis.Lab results indicated metal ion levels above 7ppb.Part/lot is being updated.The complaint was updated on:(b)(6)2016 (b)(6)/17--x-ray images received on disc (x5) sm update: (b)(6)/2017 medical records received.After review of the medical records for mdr reportability, there was no new information provided that would affect the existing investigation.The complaint was updated: (b)(6)/2017 update (b)(6)/17, (b)(6)/17 - pfs and medical records received.After review of the medical records for mdr reportability, it is determined that there is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6)/2017 update: (b)(6)2017 medical records received.After review of the medical records for mdr reportability, there was no new information provided that would affect the existing investigation.The complaint was updated: (b)(6)/2017 update (b)(6)/2017, (b)(6)/2017 medical records received.After review of the medical records for mdr reportability, there was no new information provided that would affect the existing investigation.The complaint was updated:(b)(6)/2017.

Manufacturer Narrative

Event Description

Ppf alleges abductor muscle repair, pseudo tumor, metal wear and elevated metal ions however there is no values of laboratory.Updated associated contacts, account name, report source, patient identifier, dob, and patient harm.

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, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 4 HI OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 5736642
• MDR Text Key: 47767992
• Report Number: 1818910-2016-21772
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/14/2016

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: 101214040
• Device Lot Number: D5NDN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 06/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 06/29/2018; 09/14/2018; 10/10/2018
• Supplement Dates FDA Received: 07/08/2016; 11/02/2016; 12/05/2016; 03/14/2017; 07/09/2018; 09/17/2018; 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100