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

Model Number	509-02-56E
Medical Device Problem Codes	Loss of Osseointegration (2408); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
Surgeon revised a cup, 2 screws, head, sleeve and liner with a larger, re-positioned cup and mdm liner due to dislocation.
Additional Manufacturer Narrative
An event regarding cup malposition involving a tritanium shell was reported.The event was confirmed through the medical review.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was performed and concluded: "cup malposition contributed to impingement and recurrent dislocation with additional cup loosening requiring revision." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a medical was performed and concluded that "cup malposition contributed to impingement and recurrent dislocation with additional cup loosening requiring revision." no further investigation is required at this time.If further relevant information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Surgeon revised a cup, 2 screws, head, sleeve and liner with a larger, re-positioned cup and mdm liner due to dislocation.

• 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: 6529262
• Report Number: 0002249697-2017-01397
• Device Sequence Number: 16333662
• Product Code: LPH
• UDI-Device Identifier: 07613327025156
• UDI-Public: (01)07613327025156(11)160419(17)210430(10)6T8V53
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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 Expiration Date: 04/30/2021
• Device Model Number: 509-02-56E
• Device Catalogue Number: 509-02-56E
• Device Lot Number: 6T8V53
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 07/21/2017
• 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: 51 YR