MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 31MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-031; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-031
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's left hip was revised due to pain and pseudo tumor.Head and liner were revised to an adm/mdm liner construct and ceramic head.The well-fixed and well-positioned shell and stem were not revised.
Additional Manufacturer Narrative
Additional information: d7 date of explant.An event regarding altr and pain involving a restoration modular body head was reported.The event was not confirmed.Device evaluation and results: not performed as the reported device was not returned for evaluation.A medical review was not performed because no medical information was provided.Review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Review indicated there have been no other similar events for the reported lot.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that patient's left hip was revised due to pain and pseudo tumor.Head and liner were revised to an adm/mdm liner construct and ceramic head.The well-fixed and well-positioned shell and stem were not revised.

• Brand Name: 31MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-031
• 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: 7718780
• Report Number: 0002249697-2018-02302
• Device Sequence Number: 19109307
• Product Code: LPH
• UDI-Device Identifier: 07613154057788
• UDI-Public: 07613154057788
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2018

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: 07/31/2016
• Device Catalogue Number: 6276-1-031
• Device Lot Number: 37230301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/31/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 92