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

Model Number	1235-2-561
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2020
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device not returned.
Event or Problem Description
As reported: patient had his right hip revised.The rejuvenate modular stem and neck were removed and replaced by a restoration modular stem.Surgeon also replaced the adm acetabular cup with a titanium revision shell.Patient's chromium level was less than 1.0 and his cobalt level was less than 0.5.
Event or Problem Description
As reported: patient had his right hip revised.The rejuvenate modular stem and neck were removed and replaced by a restoration modular stem.Surgeon also replaced the adm acetabular cup with a tritanium revision shell.Patient's chromium level was less than 1.0 and his cobalt level was less than 0.5.
Additional Manufacturer Narrative
Corrected the expiration date.Reported event an event regarding revision involving an adm shell was reported.The event was not confirmed.Method & results product evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records was rejected by a clinical consultant stated the following comment: spinal anesthesia/posterior approach.Components: adm 36mm acet, #5 rejuvinate stem, 42 mm neutral neck, 28/0 ceramic head." acetabular defects packed with autologous bone from acetabular reamings." uncomplicated surgery described.No clinical or pmh, no revision operative report or description of findings, no surgical pathology or lab reports, no imaging studies, no examination of explanted components.Based upon the primary op report alone, neither confirmation of the event description nor preparation of a medical report is possible for this case.-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 have been no other similar events for the lot referenced.Conclusions: it was reported that patient had his right hip revised.The event was not confirmed.A review of the provided medical records was rejected by a clinical consultant stated the following comment: spinal anesthesia/posterior approach.Components: adm 36mm acet, #5 rejuvinate stem, 42 mm neutral neck, 28/0 ceramic head." acetabular defects packed with autologous bone from acetabular reamings." uncomplicated surgery described.No clinical or pmh, no revision operative report or description of findings, no surgical pathology or lab reports, no imaging studies, no examination of explanted components.Based upon the primary op report alone, neither confirmation of the event description nor preparation of a medical report is possible for this case.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 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• 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: 10572430
• Report Number: 0002249697-2020-01974
• Device Sequence Number: 11511368
• Product Code: LPH
• UDI-Device Identifier: 04546540638786
• UDI-Public: 04546540638786
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 03/31/2014
• Device Model Number: 1235-2-561
• Device Catalogue Number: 1235-2-561
• Device Lot Number: G2670421
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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: 77 YR
• Patient Weight: 109