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

Model Number	502-03-50D
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a tritanium shell was reported.The event was confirmed through clinician review of the provided medical records.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirm that in 2018 the patient had a revision of a press fit hip that had been implanted in 2014.At her one year follow up visit the surgeon felt that the global hip pain she was experiencing was caused by lack of solid bony fixture of her cup.It is likely the revision for pain was related to fibrous rather than bony fixation of her acetabular component.Product 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: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirm that in 2018 the patient had a revision of a press fit hip that had been implanted in 2014.At her one year follow up visit the surgeon felt that the global hip pain she was experiencing was caused by lack of solid bony fixture of her cup.It is likely the revision for pain was related to fibrous rather than bony fixation of her acetabular component.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not available.
Event or Problem Description
As reported: "patient was hard to reach after 1 year visit since she moved.Had tried several times to contact her and get her to come in for a follow up visit and she was unreachable.Finally got hold of her today 2/26/2020 and she informed she had a total hip revision on her right hip in 2018." "per patient, revision was result of pain in hip." medical review: "review of these records confirm that in 2018 the patient had a revision of a press fit hip that had been implanted in 2014.At her one year follow up visit the surgeon felt that the global hip pain she was experiencing was caused by lack of solid bony fixation of her cup.It is likely the revision for pain was related to fibrous rather than bony fixation of her acetabular component.".

• 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: 9873507
• Report Number: 0002249697-2020-00593
• Device Sequence Number: 13593410
• Product Code: LPH
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 11/30/2018
• Device Model Number: 502-03-50D
• Device Catalogue Number: 502-03-50D
• Device Lot Number: MMJ78E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/24/2020
• 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: 52 YR
• Patient Weight: 57