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

Catalog Number	509-02-60F
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner and ceramic head was reported.The event was not confirmed, however, from the medical records provided it is indicated that excessive acetabular component version is present.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: the x-ray suggests that excessive acetabular component version is present.No confirmation of dislocation of the left total hip arthroplasty requiring revision surgery on (b)(6) 2019 is available, but the x-ray suggestion of acetabular malposition may have resulted in impingement and subsequent dislocation from this cause.Examination of the explanted components and additional imaging studies, along with the dictated operative report and findings would be helpful in determining the cause of the instability and rule out factors associated with implant manufacturing or materials.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including examination of the explanted components and additional imaging studies, along with the dictated operative report and findings would be helpful in determining the cause of the event and rule out factors associated with implant manufacturing or materials.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Surgeon revised a total hip - the liner, head and sleeve from a 44 to an mdm due to dislocation.The original surgery date was unknown; however, a revision surgery was done on (b)(6) 2011 to address a loose cup.Update 26 mar 2019: medical review indicates "the x-ray suggests that excessive acetabular component version is present.".

• 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: 8538087
• Report Number: 0002249697-2019-01676
• Device Sequence Number: 10856006
• Product Code: LPH
• UDI-Device Identifier: 07613327025163
• UDI-Public: 07613327025163
• 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
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 02/28/2016
• Device Catalogue Number: 509-02-60F
• Device Lot Number: MJTAYP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/22/2019
• 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: 72 YR