MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-52D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Dr.Contacted us for a mdm luxated by a patient with a tha.The primary surgery took place in 2014 (exeter stem and tritanium solid cup).There was an acetabular revision in 2017.The exact date is unknown additional patient records/ x-rays and operation reports are not available in this case this is a pi related to (b)(4) and is reported for a primary revision that had taken place within the same patient.
Additional Manufacturer Narrative
An event regarding dislocation between a v40 head and x3 liner was reported.Clinician review of the provided x-rays confirms malposition involving a tritanium shell.Method & results: product evaluation and results: not performed as no product was returned for evaluation, it remains implanted.Clinician review: two major component malposition factors active in the hip joint with non-anatomical anteversion and inclination in the arthroplasty in combination with two additional soft tissue related instability factors regarding short leg length and use of a 22-mm femoral head that may further increase capsular laxity while effective rom of a 22-mm femoral is relatively small and thereby has minimal tolerance for component malposition issues with major risk of impingement in the arthroplasty to result in hip instability ultimately leading to hip revision.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion.Two major component malposition factors active in the hip joint with non-anatomical anteversion and inclination in the arthroplasty in combination with two additional soft tissue related instability factors regarding short leg length and use of a 22-mm femoral head that may further increase capsular laxity while effective rom of a 22-mm femoral is relatively small and thereby has minimal tolerance for component malposition issues with major risk of impingement in the arthroplasty to result in hip instability ultimately leading to hip revision.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dr.Contacted for a mdm luxated by a patient with a tha.The primary surgery took place in 2014 (exeter stem and tritanium solid cup).There was an acetabular revision in 2017.The exact date is unknown additional patient records/ x-rays and operation reports are not available in this case this is a pi related to pi 2067592 and is reported for a primary revision that had taken place within the same patient.Updated based on medical review.This pi relates to first revision surgery which occurred in 2017 due to dislocation between the femoral head and x3 liner.The medical review revealed.- cup malposition with non-anatomical anteversion and inclination - short left leg with 1-cm contributing to soft tissue laxity around the hip - use of 22-mm femoral head has small effective rom and thereby minimal tolerance against impingement an unknown exeter stem was added to the product grid in this complaint investigation based on the medical review for limb length discrepancy and migration.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM
• 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: 8619206
• Report Number: 0002249697-2019-01970
• Device Sequence Number: 254820
• Product Code: LPH
• UDI-Device Identifier: 07613327040043
• UDI-Public: 07613327040043
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 08/27/2019

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 Catalogue Number: 500-03-52D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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