MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 8 HI OFFSET; HIP FEMORAL STEM/SLEEVE

Model Number	1012-14-080
Medical Device Problem Codes	Corroded (1131); Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
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
15 aug 2017: der received.It states that the patient underwent revision surgery for a painful hip.Patient had fluid collection on mri and elevated cobalt chromium levels.Asr components were removed and competitor implants were used to replace them.Update aug 16 & 17, 2017: claim letter and litigation records received.Claim letter and litigation alleges pain and suffering, and elevated metal ions.Added complainant information.
Additional Manufacturer Narrative
It states that the patient underwent revision surgery for a painful hip.Patient had fluid collection on mri and elevated cobalt chromium levels.Asr components were removed and competitor implants were used to replace them.The reported event has been evaluated and will be monitored.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.
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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: added b5, b7 and h6 (patient and device codes).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6 patient code: no code available (3191) used to capture the patient code medical device removal.
Event or Problem Description
Update ad (b)(6) 2019.(b)(4) has been reopened due to receipt of medical records.After review of medical records, the patient was revised to address a failed asr right total hip replacement with pain, osteolysis and fluid collection.Intraoperatively, cultures were taken and these were negative.A leukocyte esterase test was done and this was negative as well.The fluid collection which was the volume of a golf ball was evacuated.There was some mid blackened corrosion material on the trunnion.The stem was well-positioned and well-fixed.There was an osteolytic defect which extended into the greater trochanter.Doi: on (b)(6) 2008 - dor: on (b)(6) 2017 (right 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.H10 additional narrative: corrected: h6 (device code).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.

• Brand Name: TRI-LOCK BPS SZ 8 HI OFFSET
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6864631
• Report Number: 1818910-2017-24600
• Device Sequence Number: 19020363
• Product Code: KWA
• UDI-Device Identifier: 10603295001102
• UDI-Public: 10603295001102
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/15/2017

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
• Operator of Device: Health Professional
• Device Model Number: 1012-14-080
• Device Catalogue Number: 101214080
• Device Lot Number: CW2MT1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/10/2017; 01/08/2018; 06/14/2019; 11/21/2019; 11/15/2019; 02/18/2020
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 10/13/2017; 01/08/2018; 06/26/2019; 11/25/2019; 12/10/2019; 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR