MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: (b)(4), 6260-9-032, 32mm -4 lfit v40 head; cat# 6260-9-032; lot# 41526301.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.There have been no other events for the lot referenced.
Event or Problem Description
Patient presented with an infection of the right hip back on (b)(6) 2017.Implants were removed but distal stem was well fixed and was left behind.Osteotomy was performed and stem was removed.New restoration modular stem and body were added and tritanium revision cup and mdm liners were implanted.
Additional Manufacturer Narrative
The following product was added to the complaint after submission of the initial report.Cat.No.: unknown, unknown distal stem, lot code: unknown.An event regarding infection involving a restoration modular body was reported.The event was not confirmed.Device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: no information was received for review with the clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot or sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of device, operative reports, pathology reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.
Event or Problem Description
Patient presented with an infection of the right hip back on (b)(6) 2017.Implants were removed but distal stem was well fixed and was left behind.Osteotomy was performed and stem was removed.New restoration modular stem and body were added and tritanium revision cup and mdm liners were implanted.

• Brand Name: 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019
• 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: 6807092
• Report Number: 0002249697-2017-02559
• Device Sequence Number: 16660634
• Product Code: LPH
• UDI-Device Identifier: 04546540641069
• UDI-Public: 04546540641069
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/26/2017

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: 06/20/2021
• Device Catalogue Number: 6276-1-019
• Device Lot Number: 55328402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 10/26/2017
• 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: 34 YR
• Patient Weight: 60