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

Catalog Number	500-03-56E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	10/08/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.The event was confirmed by medical review.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "patient underwent an uncomplicated primary pressfit left tha on (b)(6) 2014.He had a normal postoperative course and was discharged the next day.The first post-operative office note available for review was dated (b)(6) 2015 six months following his surgery.In this note the patient states that he was continuing to experience the same pain that he had prior to the procedure.He had similar complaints at each successive office visit and sought second opinions.Infectious workup was completed and found to be negative.In 2016 it was noted that on his x-rays there were subtle lucencies about the acetabular component suggestive of loosening.A bone scan was performed and the results were consistent with early loosening.No action was taken at that time.He continued to have pain and was enrolled in pain management.No records were available between 2016 and early 2019.At his (b)(6) 2019 visit he continued to have complaints similar to those he had pre-op - left groin and buttock pain worsened by weight bearing.X-rays again showed lucencies about the acetabulum in (b)(6) of 2019 a ct scan of the left hip was performed.The results were consistent with acetabular loosening.Again no further action was taken.Patients complaints of pain in the groin and buttock are consistent with failure of fixation of his acetabular component.Radiographic evidence of lucencies around this component were present at his 6 month postoperative visit and have progressed over time." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient had pain, additionally it was noted that the acetabular component was loose.The available medical records were provided to the consulting clinician for a review which concluded that patients complaints of pain in the groin and buttock are consistent with failure of fixation of his acetabular component.Radiographic evidence of lucencies around this component were present at his 6 month postoperative visit and have progressed over time.The exact cause of the event could not be determined because insufficient information was provided.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
Patient called stating he had a left hip replacement done on (b)(6) 2014.He reported severe pain and would like to known if his implants were involved in a recall.As per the attached medical review," in 2016 it was noted that on his x-rays there were subtle lucencies about the acetabular component suggestive of loosening.A bone scan was performed and the results were consistent with early loosening.".

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK 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: 9416496
• Report Number: 0002249697-2019-03953
• Device Sequence Number: 2669939
• Product Code: LPH
• UDI-Device Identifier: 07613327040029
• UDI-Public: 07613327040029
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 06/30/2019
• Device Catalogue Number: 500-03-56E
• Device Lot Number: MNK6M7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/05/2019
• 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: 56 YR
• Patient Weight: 113