MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-54E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
On (b)(6) 2013, a patient had the procedure with primary tritanium hemi cluster hole cup 54mm.At the regular visit, the surgeon noticed that the patient had pain after hearing from him carefully.X-ray reveled that the cup was moving.It was due to occurrence of clear zone and loosening of the cup.The patient had revision surgery on (b)(6) 2020.The reporter¿s request: please investigate, if bone tissue is recognized over the removed cup, and the cause of occurrence of clear zone.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a tritanium shell was reported.The event was confirmed.Method & results: device evaluation and results: material evaluation was completed and indicated: the sem analysis on the shell showed that the material deformation was consistent with impaction against a hard object.The eds analysis showed that the shell base alloy and porous coatings were consistent with the drawing.Biological material consistent with bone was observed in the pores of the titanium coating.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: [.] x-ray dated (b)(6) 2019 ap left hip demonstrating uncemented tha with 1 screw visible in acetabular component, reduced, 3 to 5 mm lucencies in charley zones 2 and 3 around acetabulum consistent with failure of boney ingrowth of acetabular component.[.] the x-ray confirms the event description.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: a review of the provided x-rays by a clinical consultant indicated: x-ray [.] demonstrating uncemented tha with 1 screw visible in acetabular component, reduced, 3 to 5 mm lucencies in charley zones 2 and 3 around acetabulum consistent with failure of boney ingrowth of acetabular component.The x-ray confirms the event description.The material deformation was consistent with impaction against a hard object.The shell base alloy and porous coatings were consistent with the drawing.Biological material consistent with bone was observed in the pores of the titanium coating.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
On (b)(6) 2013, a patient had tha procedure with primary tritanium hemi cluster hole cup 54mm.At the regular visit, the surgeon noticed that the patient had pain after hearing from him carefully.X-ray reveled that the cup was moving.It was due to occurrence of clear zone and loosening of the cup.The patient had revision surgery on (b)(6) 2020.The reporter¿s request: 1) please investigate, if bone tissue is recognized over the removed cup, and 2) the cause of occurrence of clear zone.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• 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: 9963697
• Report Number: 0002249697-2020-00748
• Device Sequence Number: 16858313
• Product Code: LPH
• UDI-Device Identifier: 07613327040142
• UDI-Public: 07613327040142
• Combination Product (Y/N): N
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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 Model Number: 502-03-54E
• Device Catalogue Number: 502-03-54E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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: 50 YR