MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 6 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-04-060
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Injury (2348); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Reporter is an attorney.
Event or Problem Description
Litigation alleges that patient experienced severe and permanent injuries, conscious pain and suffering.Doi: (b)(6) 2008; dor: none reported; (unknown side).Patient is a resident of (b)(6).Update 05/21/2012 plaintiff's preliminary disclosure (ppd) form and implant log received which identified part/lot information and the patient's date of birth.Product updated and femoral head added.Mdr decision tree completed and appropriate mdrs submitted.Ppd w/log attached to the file.There is no new information that would change the outcome of the investigation.(b)(6).Update ad 7 agg 2018: (b)(4) has been re-opened under (b)(4) due to receipt of a der.It was reported that the left hip asr cup revised - painful left hip with elevated chromium levels.Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Litigation alleges that patient experienced injuries, pain, and elevated chromium levels.Doi: (b)(4), 2008 dor: (b)(4), 2018 left hip.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: 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: 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 will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 : 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 or Problem Description
Medical records received.After review of medical records, patient was revised to address status post metal on metal left total hip arthroplasty with metallosis.Patient alleges elevated metal ions, metallosis, and pain.Operative notes stated of scar tissue along the posterior aspect of the gluteus maximus along the vastus lateralis.Pseudotumor was noted underlying the external rotators.There was normal-appearing joint fluid, but did have some loose soft tissue around the cup within the hip capsule.There was evidence of black debris along the base of the trunnion before the head was knocked off.There was a very little bone on the backside of the cup when it was removed.The patient did have a bit of a deficient anterior wall, but had adequate bone stock superiorly and posteriorly.
Additional 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 caused or contributed to the potential event described in this report.H10 additional narrative: udi: (b)(4).Added: h6(patient and device).Corrected: a2(age).H6 patient code: no code available (3191) used to capture the surgical intervention and blood heavy metal increased.
Additional 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 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 null device history batch null device history review null.

• Brand Name: TRI-LOCK BPS SZ 6 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7832295
• Report Number: 1818910-2018-68123
• Device Sequence Number: 19223748
• Product Code: KWA
• UDI-Device Identifier: 10603295000778
• UDI-Public: 10603295000778
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 1012-04-060
• Device Catalogue Number: 101204060
• Device Lot Number: C5FB31000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018; 07/26/2019; 12/31/2019; 04/15/2020; 04/24/2020
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 08/30/2018; 10/23/2019; 01/20/2020; 04/23/2020; 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 65