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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Right hip: during a revision acetabular procedure a trident tritanium shell was implanted.5 screws were used from the restoration gap plate screw caddy, all packages were checked by surgeon and scrub nurse.In a post-op x-ray it was observed that a screw was disassociated from the cup.When usage stickers were checked, it was discovered that one of the screws was a torx cancellous bone screw, not a restoration gap plate screw.Update 21/february/2019: as reported in adverse consequence details "surgeon said that he had attempted to use the screw in the superior pubic ramus to lag a fracture.He had during the procedure plated the posterior of the acetabulum.Fx in superior pubic ramus wasn¿t disclosed during surgery.Post surgery, the patient had attempted to weight bear and reported pain.X-ray was taken which also showed a fracture in the inferior pubic ramus.Surgeon said he is unsure what the next step will be at this stage." update 26-feb-2019: "the procedure was removing what was believed to be an old competitor cup.Initially the case was booked as abg removal; however the cup was definitely not an abg - i identified on the x-ray that it wasn¿t an abg and the abg instruments were not compatible sizes.The cup was also not any other stryker or howmedica cups that were available at that time.".

• 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: 8438717
• Report Number: 0002249697-2019-01391
• Device Sequence Number: 277958
• Product Code: LPH
• UDI-Device Identifier: 07613327025149
• UDI-Public: 07613327025149
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 03/20/2019

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: 07/31/2023
• Device Catalogue Number: 509-02-54E
• Device Lot Number: JV70X6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/20/2019
• 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: Other