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 Code	Inadequate Osseointegration (2646)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.Not returned.
Event or Problem Description
Dr.Revised a cup/ head/ liner due to cup loosening.He revised a tritanium cup sz 54 with a single 6.5 x 35 torx screw to a multihole cup sz 58.The original surgery was done on (b)(6) 2012.Rep also reported that the above revised screw was broken, and that the tip of the screw was left in the patient's left hip.
Additional Manufacturer Narrative
Corrected the manufacturing date.Reported event:  an event regarding loosening involving primary tritanium hemi cluster hole cup 54mm was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photos provided show a significant amount of blood on the the explanted shell.There is nothing else remarkable of note.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records and x-rays was rejected by a clinical consultant indicating: undated, unlabeled partial page of operative report "left total hip arthroplasty" post-op diagnosis; "left hip osteoarthritis - end stage" "implants used: 54 mm titanium shell, 1 screw - 35 mm, 0 degree x3 insert, #5 accolade ii stem, 40/0 femoral head." no procedure description included.No clinical or pmh, no patient demographics, no imaging studies, no complete operative reports, no examination of explanted components.Based upon the single, partial document supplied, neither confirmation of the event description nor preparation of a medical report is possible for this case.-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 dr.Revised a cup/head/liner due to cup loosening.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Dr.Revised a cup/head/liner due to cup loosening.He revised a tritanium cup sz 54 with a single 6.5x35 torx screw to a multihole cup sz 58.The original surgery was done on (b)(6) 2012.Rep also reported that the above revised screw was broken, and that the tip of the screw was left in the patient's left hip.

• 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: 10527293
• Report Number: 0002249697-2020-01857
• Device Sequence Number: 19612702
• Product Code: LPH
• UDI-Device Identifier: 07613327040142
• UDI-Public: 07613327040142
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 11/09/2020

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: 11/30/2017
• Device Model Number: 502-03-54E
• Device Catalogue Number: 502-03-54E
• Device Lot Number: MLPJ5D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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: 83 YR