MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ANATOMIC SHELL SIZE 56 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	504-02-56D-L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The patients left hip was revised due to a loose cup.
Additional Manufacturer Narrative
Additional information in b5 event description.An event regarding loosening involving a restoration anatomic shell size 56 left was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as device was not returned.-medical records received and evaluation: not performed as medical records were not provided.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there have been no other events for the lot referenced.Conclusions: discussion with dr.(b)(6) indicated that at the time of ras shell implantation, the patient had poor bone quality as a result of multiple previous revisions and a near pelvic discontinuity.Bone graft was used around the shell as well, but the patient's existing conditions aforementioned affected the ability for the bone to achieve fixation however, the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays and the operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.
Event or Problem Description
The patients left hip was revised due to a loose cup.Update: "surgeon indicated that at the time of ras shell implantation, the patient had poor bone quality as a result of multiple previous revisions and a near pelvic discontinuity.Bone graft was used around the shell as well, but the patient's existing conditions aforementioned affected the ability for the bone to achieve fixation.".

• Brand Name: RESTORATION ANATOMIC SHELL SIZE 56 LEFT
• 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: 6306999
• Report Number: 0002249697-2017-00472
• Device Sequence Number: 19122552
• Product Code: LPH
• UDI-Device Identifier: 07613327012361
• UDI-Public: (01)07613327012361(11)151023(17)201031(10)W03J5W
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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: 10/31/2020
• Device Catalogue Number: 504-02-56D-L
• Device Lot Number: W03J5W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 04/06/2017
• 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: 56 YR
• Patient Weight: 73