MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 20 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-7-020
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/11/2017
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 reported discrepancies.There have been no other 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.
Event or Problem Description
It was reported that a surgeon performed a revision of a patient's right hip after the patient complained of pain.The surgeon reported that implant had subsided.The procedure was completed successfully with no delays.
Additional Manufacturer Narrative
An event regarding subsidence involving a restoration modular stem was reported.The event was confirmed following a review by a clinical consultant.Device evaluation and results: not performed as the device was not returned for analysis.Medical records received and evaluation: a review by a clinical consultant noted: as such is root cause of failure determined by the poor quality of the present bone in the proximal femur without attempts at reconstruction of bone stock to improve the load carrying properties of the local bone.It might have been better to improve proximal femoral bone stock by using cortical strut grafts that not only improve the biological potential of the remaining bone but also provide a better purchase point for the application of dm-cables over the native remaining bone.If this was not feasible for whatever reasons, a gmrs type of proximal hip replacement could present a reasonable alternative although bone graft reconstruction is usually preferable.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: a review by a clinical consultant concluded: hip device implantation in poor bone quality with major bone defects after previous device failures without attempts at improving bone stock or alternatives has resulted in an overload condition of the bone supporting the newly implanted device preventing effective bone ingrowth.Device loosening required revision.If devices and/or additional information become available, this investigation will be reopened.
Event or Problem Description
It was reported that a surgeon performed a revision of a patient's right hip after the patient complained of pain.The surgeon reported that implant had subsided.The procedure was completed successfully with no delays.

• Brand Name: MOD CON DIST STEM 20 X 155 MM
• 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: 6852625
• Report Number: 0002249697-2017-02711
• Device Sequence Number: 18943628
• Product Code: LPH
• UDI-Device Identifier: 04546540643780
• UDI-Public: 04546540643780
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/08/2017

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: 11/18/2021
• Device Catalogue Number: 6276-7-020
• Device Lot Number: CAXV50MA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: 66 YR