MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1235-2-601
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	01/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
This pi is for the first revision of the patient's right hip.In reporting a revision of the patient's hip on (b)(6) 2020, rep was told the patient had a prior revision approximately 8 years ago due to the adm shell being in a vertical position.The adm shell, adm insert and 28 +0 v40 head were revised to a tritanium hemispherical cluster hole shell with 2 screws, a 44g insert, and 44 +4 lfit head.Rep was not present for the procedure.
Event or Problem Description
This pi is for the first revision of the patient's right hip.In reporting a revision of the patient's hip on (b)(6) 2020, rep was told the patient had a prior revision approximately 8 years ago due to the adm shell being in a vertical position.The adm shell, adm insert and 28 +0 v40 head were revised to a tritanium hemispherical cluster hole shell with 2 screws, a 44g insert, and 44 +4 lfit head.Rep was not present for the procedure.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a adm 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: a review of the provided medical information by a clinical consultant indicated: insufficient data is presented to confirm the event description for pi - or to create a medical report for this case.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 23 sept 2010 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: RESTORATION (TM) ADM. CUP W/HA
• 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: 11001129
• Report Number: 0002249697-2020-02661
• Device Sequence Number: 703904
• Product Code: LPH
• UDI-Device Identifier: 04546540638823
• UDI-Public: 04546540638823
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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 Model Number: 1235-2-601
• Device Catalogue Number: 1235-2-601
• Device Lot Number: G2989654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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: 67 YR