MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	509-02-58F
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 25mm mod rev hip bdy/blt +20mm component level 9006-1-225; cat#:6276-1-225; lot#: unknown, unknown mdm liner; cat#:unknown; lot#: unknown, unknown 28mm v40 lfit head-6260-0-228; cat#:unknown; lot#: unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Revision of a total hip due to acute infection and malposition of the acetabular cup.
Additional Manufacturer Narrative
Corrected data: manufacturing site for devices.An event regarding infection and malposition involving a trident shell was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of the device history records indicates 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 lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection and malposition.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision 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.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: 6276-1-025; 25mm mod rev hip body/bolt stdcomponent level 9006-1-025; lot#:52322002 626-00-46f; modular dual mobility insert; lot#:51411902.6260-5-228; 28mm +4 v40 taper vit head; lot#:51076904.6276-7-017; mod con dist stem 17 x 155 mm; lot#: caxt42nc.2080-0030; gap plate screws 30mm; lot#: w865r0.2080-0040; gap plate screws 40mm; lot#:3m1w4p.6704-0-510; md vit slv and 2.0mm homog cbl; lot#:53099001.6704-0-510; md vit slv and 2.0mm homog cbl; lot#:52554010.6704-6-020; vit cable grip medium 2.0mm; lot#:52418801.1236-2-852; restoration adm x3 ins 28/52; lot#:51715901.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Revision of a total hip due to acute infection and malposition of the acetabular cup.

• Brand Name: TRITANIUM REVISION ACETABULAR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6433087
• Report Number: 0002249697-2017-01012
• Device Sequence Number: 16268647
• Product Code: LPH
• UDI-Device Identifier: 07613327025170
• UDI-Public: 07613327025170
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K010170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024
• 2 Devices were Involved in the Event: 1 2

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: 08/31/2020
• Device Catalogue Number: 509-02-58F
• Device Lot Number: 9T78HE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female