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

Model Number	500-03-50D
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
It was reported that the patient's right hip was revised due to trunnionosis and shell loosening.Intra-operatively, black material inside the femoral head and pseudotumor were noted.The patient's shell, liner, and femoral head were revised to a new stryker shell, liner, and ceramic head with sleeve.Rep confirmed there are no allegations against the revised liner.Rep also confirmed the femoral head will be returned.The surgeon is requesting investigation results for the femoral head.
Event or Problem Description
It was reported that the patient's right hip was revised due to trunnionosis and shell loosening.Intra-operatively, black material inside the femoral head and pseudotumor were noted.The patient's shell, liner, and femoral head were revised to a new stryker shell, liner, and ceramic head with sleeve.Rep confirmed there are no allegations against the revised liner.Rep also confirmed the femoral head will be returned.The surgeon is requesting investigation results for the femoral head.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving tritanium shell was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: she underwent a right tha with computer aided navigation on (b)(6) 2013.The implants utilized included: a secure-fit max 132°, size #9 c-taper, trident x3 o0 36 inner diameter liner, tritanium hemispheric solid back shell 50mm, and an lfit c-taper femoral head 36mm +2.5mm.When seen postoperatively (b)(6) 2013, the patient was having some pain and weakness, but her wounds looked good.Her x-ray showed good implant position.There were no identified problems and a plan was put forth to start pt in a week.There was a gap in the record until (b)(6) 2020.[.] on (b)(6) 2020, the patient was having right thigh pain that was worse with activity, a pain level of 10/10.The revision surgery was performed on (b)(6) 2020.[.] a large pseudo tumor was debrided.There was significant osteolysis of the greater trochanter.The acetabular component was found to be loose and was removed.The real polyethylene liner and head/sleeve were impacted, and the hip reduced.Prior to impacting the head, the trunnion was cleaned "of all the wear and trunnionosis", [.] conclusion of assessment: the right hip was revised and a pseudotumor noted.Metal levels were mildly abnormal, "trunnionosis" was passively described.The acetabular component was loose and may have contributed to the findings.Obtaining the implant may provide insight into mechanism of failure, presence or lack of trunnionosis, whether femoral head was a part of a recall, and whether the acetabulum was a source of debris.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 medical records by a clinical consultant indicated, metal levels were mildly abnormal, "trunnionosis" was passively described.The acetabular component was loose and may have contributed to the findings.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK 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: 10210688
• Report Number: 0002249697-2020-01322
• Device Sequence Number: 2668621
• Product Code: LPH
• UDI-Device Identifier: 07613327040005
• UDI-Public: 07613327040005
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• 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,other
• 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 Expiration Date: 07/31/2012
• Device Model Number: 500-03-50D
• Device Catalogue Number: 500-03-50D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 06/30/2020
• 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: 71 YR