MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	2041C-3258
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
While performing a revision of the patient's right hip, the poly would not fully lock into the shell.The device appeared flush (not sitting proud), but still allowed micro-motion within the shell.A second poly was opened and used with no issues.A surgical delay of approximately 10 minutes was reported.Rep reported that hospital will release no further information due to its interpretation of hipaa.Update 25-jul-2018: rep provided a usage sheet which also showed a series ii liner as wasted.Rep reported that the surgeon had tried that liner first, but it wasn't stable.Surgeon then tried the second liner originally reported.A screw, also wasted, was only used to remove the 2 reported liners.Update 26-jul-2018: rep addressed the report of the series ii liner being unstable: "the instability was related to the rom and likely associated to the patients soft tissue anatomy from revision surgery.It was not related to the implant".The series ii implant was disposed by the hospital.
Additional Manufacturer Narrative
An event regarding rom and instability involving an omnifit liner was reported.The event was not confirmed.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
While performing a revision of the patient's right hip, the poly would not fully lock into the shell.The device appeared flush (not sitting proud), but still allowed micro-motion within the shell.A second poly was opened and used with no issues.A surgical delay of approximately 10 minutes was reported.Rep reported that hospital will release no further information due to its interpretation of hipaa.Update 25-jul-2018: rep provided a usage sheet which also showed a series ii liner as wasted.Rep reported that the surgeon had tried that liner first, but it wasn't stable.Surgeon then tried the second liner originally reported.A screw, also wasted, was only used to remove the 2 reported liners.Update 26-jul-2018: rep addressed the report of the series ii liner being unstable: "the instability was related to the rom and likely associated to the patients soft tissue anatomy from revision surgery.It was not related to the implant".The series ii implant was disposed by the hospital.

• Brand Name: CROSSFIRE 10 DEG INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7788277
• Report Number: 0002249697-2018-02551
• Device Sequence Number: 13746991
• Product Code: JDI
• UDI-Device Identifier: 04546540035813
• UDI-Public: 04546540035813
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K974685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 2041C-3258
• Device Lot Number: 58408201
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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: Other
• Patient Age: 73 YR