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

Device Problems Failure to Osseointegrate (1863); Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 01/02/2018

Event Type  Injury  

Manufacturer Narrative

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.Review of the device history records indicate that devices were manufactured and accepted on into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

It was reported that patient's right hip was revised.Cause not explicitly reported but a video sent by the rep has the following surgeon reports: "i just shelled the cup out, and can see the marks in the bone corresponding to the ridges on the tritanium.Absolutely no bony ingrowth; there's no bone loss at all, the only thing holding this cup was that one screw that i put in.".

Manufacturer Narrative

An event regarding loosening involving a titanium acetabular shell was reported.The event was confirmed by medical review.Method & results: product evaluation and results: the device was not returned, however, an image of the explanted acetabular shell was attached.It showed blood and biological material adhered to the porous structure of the shell.Clinician review: a review of the provided medical reviews and x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no patient demographics, no revision operative report, and no examination of the explanted components are available.X-rays labeled ¿two weeks¿¿ and ¿three months¿ post-op¿ suggest incomplete medialization and bony contact of the acetabulum, possibly due to under remaining of 2-millimeters in this male patient with good quality bone.There is no history given of medications, disease states, or other clinical factors that could discourage biologic fixation in this case.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.¿ product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event of loosening of the acetabular shell was confirmed by the clinician.Based on the clinician¿s review, ¿x-rays labeled ¿two weeks¿¿ and ¿three months¿ post-op¿ suggest incomplete medialization and bony contact of the acetabulum, possibly due to under remaining of 2-millimeters in this male patient with good quality bone.¿ the exact root cause could not be determined based on missing medical documentation to make further assessment.If further medical information is received the complaint will be reopened and reassessed.

Event Description

It was reported that patient's right hip was revised.Cause not explicitly reported but a video sent by the rep has the following surgeon reports: "i just shelled the cup out, and can see the marks in the bone corresponding to the ridges on the titanium.Absolutely no bony ingrowth; there's no bone loss at all, the only thing holding this cup was that one screw that i put in.".

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7220072
• MDR Text Key: 98277850
• Report Number: 0002249697-2018-00246
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 502-03-56E
• Device Lot Number: T3767W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR