MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-50D
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	09/04/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: ".Patient came into the office complaining of pain.At that time he had the patient get xrays of the hip.With further investigation it appeared that the cup had lucencies around it.He monitored the patients pain and activity levels and eventually decide to have the implant revised.Upon revising the cup it appeared to have a little bony ongrowth around perimeter of the shell in a couple of small locations." update: "left side.".
Event or Problem Description
As reported: ".Patient came into the office complaining of pain.At that time he had the patient get xrays of the hip.With further investigation it appeared that the cup had lucencies around it.He monitored the patients pain and activity levels and eventually decide to have the implant revised.Upon revising the cup it appeared to have a little bony ongrowth around perimeter of the shell in a couple of small locations." update: "left side.".
Additional Manufacturer Narrative
An event regarding shell loosening involving a tritanium shell was reported.The event was not confirmed.Method & results product evaluation and results: visual inspection was performed as part of the material evaluation and indicated the following comments."damage consistent with the implantation/explantation process was observed on the proximal surface, distal rim, and distal surface.Material is consistent with the astm f67 alloy.No materials or manufacturing discrepancies were observed on the surfaces examined." dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material evaluation was completed and indicated the following comments: "damage consistent with the implantation/explantation process was observed on the proximal surface, distal rim, and distal surface.Material is consistent with the astm f67 alloy.No materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: no medical records were received for review with a clinical consultant 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 have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays 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 50MM
• 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: 9139484
• Report Number: 0002249697-2019-03348
• Device Sequence Number: 3137346
• Product Code: LPH
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 11/27/2019

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: 05/31/2018
• Device Catalogue Number: 502-03-50D
• Device Lot Number: MMJ42V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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: 79 YR
• Patient Weight: 67