MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1235-2-522

Device Problems Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient had left groin pain.The doctor states that he thinks the primary cup was too big for patient's anatomy.Also the cup did not fully osseointegrate.

Manufacturer Narrative

An event regarding pain involving an adm shell.A medical review confirmed malposition.Method and results: device evaluation and results: the device was not returned for evaluation.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: the principal problem of this case is cup malposition leading to an overload condition with cup loosening.Given the implantation time of 6-years with evidence of loosening, it is not certain whether this cup never acquired proper bony fixation or underwent secondary loosening due to an external overload condition.There is no clinical information to detail the start of clinical symptoms of groin pain, early or late after left hip arthroplasty.Normal cup position and size correspond more or less to the lower cup rim at or near the level of the ¿teardrop¿, an anatomic marker visible on x-ray, see illustration in radiology detail section.In this patient, the lower cup rim is at least 1-cm below this teardrop level and thus confirms an excessive cup size.The low cup inclination with low anteversion and deep cup placement make the system vulnerable to impingement between the neck of stem and the acetabular bone or the cup rim during a multitude of hip movements effectively representing device-bone or device-device impingement.Cup malposition with regard to position and size thus clearly represents the principal failure mode and this is a procedure-related factor because the surgeon is responsible for optimal component choice and positioning.From the patient-related perspective, there is limited information.Body weight was low normal with a bmi of (b)(6) while activity level was reported as very high which may have been a relevant secondary factor to magnify the groin pain symptoms.The higher the activity level, the more issues with friction of the ip tendon along the cup rim can be expected although this is certainly not a root factor.From the device-related perspective, there is no evidence to suppose that device-related factors have played any role in the failure mode consistent with the type of failure reported.This pi case is not device-related.Procedure-related factors: cup malposition with regard to size and lack of anteversion.Patient-related factors: high activity level can be considered a secondary factor magnifying existing symptoms.Device-related factors: none.Diagnosis: cup malposition with regard to excessive size and lack of anteversion has contributed to iliopsoas impingement with groin pain through the exposed anterior cup rim while the associated mechanical overload condition has contributed to loss of acetabular fixation also contributing to groin pain and requiring revision.Conclusions: "a review of the provided information by a clinical consultant concluded that: "- cup malposition with regard to excessive size and lack of anteversion has contributed to iliopsoas impingement with groin pain through the exposed anterior cup rim while the associated mechanical overload condition has contributed to loss of acetabular fixation also contributing to groin pain and requiring revision." further information such as returned device, additional x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

Patient had left groin pain.The doctor states that he thinks the primary cup was too big for patient's anatomy.Also the cup did not fully osteointegrate.

• Brand Name: RESTORATION (TM) ADM. CUP W/HA
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6107648
• MDR Text Key: 60071008
• Report Number: 0002249697-2016-03639
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 1235-2-522
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 44