MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BACK SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-11-50D
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding a product mix.Lot id: there have been no other similar events for the reported lot.
Event or Problem Description
Surgeon questioning whether implant was sized correctly ¿ trident hemispherical cluster shell size 50d (500-11-50d) surgeon felt shell seemed to be sized incorrectly and was actually a size 48mm.Box, stickers and implants all stated it was 500-11-50d however size in comparison to window trial and other shells seemed smaller than usual.Primary surgery.Opted to use a cemented rim-fit cup with alumina head.
Additional Manufacturer Narrative
An event regarding an appearance issue involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the device showed nothing remarkable about the device.Dimensional inspection was performed by a member of the manufacturing cell.The report provided concluded the following: the returned part is the correct size of 50mm.No inspection failures were identified with the returned part.As per the re-inspection of the returned part, it can be confirmed that the part was correct size.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: dimensional inspection of the returned device confirmed that it was within spec for the size.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Surgeon questioning whether implant was sized correctly ¿ trident hemispherical cluster shell size 50d (500-11-50d) surgeon felt shell seemed to be sized incorrectly and was actually a size 48mm.Box, stickers and implants all stated it was 500-11-50d however size in comparison to window trial and other shells seemed smaller than usual.Primary surgery.Opted to use a cemented rim-fit cup with alumina head.

• Brand Name: TRIDENT HEMISPHERICAL SOLID BACK SHELL
• 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: 8105559
• Report Number: 0002249697-2018-03822
• Device Sequence Number: 19323101
• Product Code: LPH
• UDI-Device Identifier: 04546540431851
• UDI-Public: 04546540431851
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 500-11-50D
• Device Lot Number: 66274102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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