MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-44G
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar 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.Device not returned.
Event or Problem Description
Surgeon revised a stem, head, and liner due to trunnionosis.Original surgery was (b)(6) 2007.Update 23/august/2018: rep provided explant pictures, pre-revision x-rays, primary operative report, and usage sheets from primary and revision procedures.Explant picture shows wear on the rim of the poly insert and pre-revision x-rays show the head disassociated from the stem.
Event or Problem Description
Surgeon revised a stem, head, and liner due to trunnionosis.Original surgery was (b)(6) 2007.Update 23/august/2018: rep provided explant pictures, pre-revision x-rays, primary operative report, and usage sheets from primary and revision procedures.Explant picture shows wear on the rim of the poly insert and pre-revision x-rays show the head disassociated from the stem.
Additional Manufacturer Narrative
An event regarding wear involving a trident liner was reported.The event was not confirmed.Visual inspection: although the device was not returned an image of the explanted liner was made available.The image shows damage to the rim of the liner.It cannot be confirmed if this damage is due to wear or the explantation process.A review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms femoral head dissociation from a tha femoral stem occurred secondary to remodeling and loss of material of the femoral stem trunnion.The root cause cannot be determined as insufficient information was available documentation which would aid in the further completion of this assessment would include: material analysis of the explanted implants.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The event and exact cause of the event could not be confirmed or determined because insufficient information was provided.Additional information, including the return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT 0 DEG INSERT 44MM
• 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: 7883143
• Report Number: 0002249697-2018-02910
• Device Sequence Number: 2725772
• Product Code: LPH
• UDI-Device Identifier: 07613327025385
• UDI-Public: 07613327025385
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 12/31/2012
• Device Catalogue Number: 623-00-44G
• Device Lot Number: LE3MRD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: 76 YR