MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-58F
Medical Device Problem Codes	Loss of Osseointegration (2408); Material Deformation (2976)
Health Effect - Clinical Codes	Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Tritanium cup was explanted due to loosening and loss of original cup position.In revising cup, it was noted the fixation screw had broken.Original implants, cup, liner, screw and hip ball were extracted.A tritanium revision cup, screws, mdm and hip ball were implanted.As reported in "how was issue noticed": patient discomfort.
Additional Manufacturer Narrative
An event regarding loosening involving a tritanium shell was reported.The event was confirmed by medical review.Visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2018 which indicated the tritanium cup and acetabular insert had signs of explantation damage.Scratching, burnishing and third body indentations were also observed on the acetabular insert.A material analysis has been performed.The report concluded " the tritanium cup and acetabular insert had signs of explantation damage.Scratching, burnishing and third body indentations were also observed on the acetabular insert.These are common damage modes of uhmwpe.The ceramic head had metal transfer marks likely from the explantation process and a continuous metal transfer ring in the female taper which indicates proper seating between the trunnion and hip stem.The screw fractured in fatigue.Eds showed that the screw was consistent with astm f136.Based on the given information, no identifiable material discrepancies were observed on the surfaces examined." a review of the provided medical records and/or x-rays by a clinical consultant indicated: " the primary harm involved is early loss of fixation of the acetabular shell in a pressfit tha.Early loss of fixation with change in cup position suggests that primary fixation allowing bony ingrowth did not occur.The cup was initially fixed by the screw.Because there was no ingrowth the sole means of fixation was the bone screw.The lack of bony fixation of the cup caused excessive loads to be placed upon the bone screw which ultimately failed in fatigue.There is no evidence for defect in the implants or their manufacture.No xrays , operative implant records or xrays were available for review.*it should be noted that the implant listed in the product inquiry report lists a 58mm cup while the surgeons report from the index surgery describes preparing for and implanting a 60mm cup.There is insufficient documentation presented to complete this assessment.Further documentation which would be useful in further assessing this complaint would include: operative report from revision surgery, surgical implant records from the surgeries, pre and post op xrays from the index and revision surgeries and outpatient office/clinic notes." all products in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The investigation concluded that the alleged failure mode was caused by early loss of fixation with change in cup position suggests that primary fixation allowing bony ingrowth did not occur.The root cause can not be determined as insufficient information was not provided.Further information such as operative report from revision surgery, surgical implant records from the surgeries, pre and post op xrays from the index and revision surgeries and outpatient office/clinic notes.If additional information become available, this investigation will be reopened.
Event or Problem Description
Tritanium cup was explanted due to loosening and loss of original cup position.In revising cup, it was noted the fixation screw had broken.Original implants, cup, liner,screw and hip ball were extracted.A tritanium revision cup, screws, mdm and hip ball were implanted.As reported in "how was issue noticed": patient discomfort.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM
• 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: 7248031
• Report Number: 0002249697-2018-00350
• Device Sequence Number: 18859831
• Product Code: LPH
• UDI-Device Identifier: 07613327040159
• UDI-Public: 07613327040159
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/12/2018

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: 06/30/2021
• Device Catalogue Number: 502-03-58F
• Device Lot Number: PP8D0M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 04/12/2018
• 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: 66 YR