MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-56E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/16/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Surgeon revised patient's acetabular component due to loosening of the implant.No further information was available".A loose 56mm tritanium hemispherical cluster hole shell, 6.5 x 25 bone screw, 36mm 0° x3 insert, and 36 -2.5 biolox ceramic head were revised.
Event or Problem Description
Surgeon revised patient's acetabular component due to loosening of the implant.No further information was available".A loose 56mm tritanium hemispherical cluster hole shell, 6.5 x 25 bone screw, 36mm 0° x3 insert, and 36 -2.5 biolox ceramic head were revised.
Additional Manufacturer Narrative
Added expiration date.An event regarding loosening involving trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from 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 operative reports, progress notes, x-rays and 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: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
• 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: 8333175
• Report Number: 0002249697-2019-01017
• Device Sequence Number: 1663696
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 03/31/2020
• Device Catalogue Number: 502-03-56E
• Device Lot Number: HY8AD0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 02/26/2019
• 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: 65 YR
• Patient Weight: 81