MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-56E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	05/07/2019
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.
Event or Problem Description
It was reported that the patient's left hip was revised due to aseptic shell loosening and pain.No possible cause or contributor for loosening was reported to the rep.The shell, ceramic head, and poly liner were revised to a multi-hole revision shell, mdm/adm liner construct, and a ceramic head with sleeve (there are no allegations against the revised liner or head).Rep provided a pre-revision x-ray and reported that no further information will be available.
Event or Problem Description
It was reported that the patient's left hip was revised due to aseptic shell loosening and pain.No possible cause or contributor for loosening was reported to the rep.The shell, ceramic head, and poly liner were revised to a multi-hole revision shell, mdm/adm liner construct, and a ceramic head with sleeve (there are no allegations against the revised liner or head).Rep provided a pre-revision x-ray and reported that no further information will be available.
Additional Manufacturer Narrative
Additional information: lot code an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: - device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.- clinician review: no medical records were received for review with a clinical consultant.- 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.Conclusions: it was reported that the patient's hip was revised due to aseptic loosening of shell and pain.The event could not be confirmed nor the exact cause be determined as insufficient information was available.No further investigation for this event is possible at this time as no devices and / or 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.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 56MM
• 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: 8664571
• Report Number: 0002249697-2019-02143
• Device Sequence Number: 16729436
• Product Code: LPH
• UDI-Device Identifier: 07613327040029
• UDI-Public: 07613327040029
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 03/31/2019
• Device Catalogue Number: 500-03-56E
• Device Lot Number: MNENX6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: 61 YR