MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	509-02-54E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/27/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Update per medical review: "on (b)(6) 2015 she underwent a right acetabular liner change and achilles allograft to the posterior capsule for "unstable right tha".".
Additional Manufacturer Narrative
An event regarding instability involving a tritanium shell was reported.Conclusions: medical review confirms instability, however, only the liner and head were revised.The shell and screws previously implanted remained in the patient.Medical review notes: "an office visit of november 12, 2015 notes, "doing good in brace".When seen on (b)(6) 2015 it was noted, "in abduction brace going to p.T, getting stronger".On (b)(6) 2016 she was seen and it was noted, "going to p.T.After last surgery no more dislocations, on a cane".There is no documented follow-up subsequent to this visit available." there is no indication that the cup was loose and could have lead to instability,.
Event or Problem Description
Update per medical review: "on (b)(6) 2015 she underwent a right acetabular liner change and achilles allograft to the posterior capsule for "unstable right tha".".

• Brand Name: TRITANIUM REVISION ACETABULAR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7611390
• Report Number: 0002249697-2018-01865
• Device Sequence Number: 11311375
• Product Code: LPH
• UDI-Device Identifier: 07613327025149
• UDI-Public: 07613327025149
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 509-02-54E
• Device Lot Number: 4W65TH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 61