MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-58F
Medical Device Problem Codes	Corroded (1131); Loss of Osseointegration (2408); Material Deformation (2976)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the lot referenced.There have been no other similar events for the sterile 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.
Event or Problem Description
Hip revision - mdm liner and tritanium primary cup - metal/metal wear - removed components and inserted antibiotic spacer.Patient was revised due to deep infection.Patient also had a pelvic fracture and the shell was found to have migrated medially, through the medial wall.Corrosion on the back of the metal liner was also reported.
Additional Manufacturer Narrative
An event regarding infection, periprosthetic acetabular fracture, loosening, wear and corrosion involving a tritanium shell was reported.The event was not confirmed.Method & results: product evaluation and results: the device was not returned however, one photo of the explanted shell was provided.The shell shows some biological material on the outer surface and rim of the shell.There are some marks on the inner surface of the shell but it is unclear what these are.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot and sterile lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Hip revision - mdm liner and tritanium primary cup - metal/metal wear - removed components and inserted antibiotic spacer.Patient was revised due to deep infection.Patient also had a pelvic fracture and the shell was found to have migrated medially, through the medial wall.Corrosion on the back of the metal liner was also reported.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM
• 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: 7611181
• Report Number: 0002249697-2018-01857
• Device Sequence Number: 13483697
• Product Code: LPH
• UDI-Device Identifier: 07613327040159
• UDI-Public: 07613327040159
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 08/03/2018

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: 02/28/2019
• Device Catalogue Number: 502-03-58F
• Device Lot Number: MNA72L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/03/2018
• 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