MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	1236-2-244
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/22/2019
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.Device not returned.
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.An mdm liner was placed.This was luxated.The mdm liner was removed and a constrained liner was placed.The v40 22.2 / +3 head was out of de x3 restoration liner ((b)(6) 2019).Additional patient records/ x-rays and operation reports are not available in this case.
Event or Problem Description
Dr.(b)(6) 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.An mdm liner was placed.This was luxated.The mdm liner was removed and a constrained liner was placed.The v40 22.2 / +3 head was out of de x3 restoration liner (b)(6) 20019).Additional patient records/ x-rays and operation reports are not available in this case update 24 july 2019 based on medical review.This pi relates to the second revision surgery which occurred (b)(6) 2019 due to dislocation.An x-ray on (b)(6) 2019, documented an intraprosthetic dislocation of the mdm construct with migration of the stem in superior direction.Cup shell and stem position remain unchanged from previous descriptions (shell malposition) because retained during revision surgery in 2017 with only conversion of the bearing in the trident shell for an mdm construct with new v40 22-mm/+3 femoral head.A second revision surgery was performed on (b)(6) 2019 with exchange of the mdm bearing for a constrained cup insert system with new v40 22- mm/+0 femoral head.The new arthroplasty condition was documented on post revision x-ray on (b)(6) 2019.
Additional Manufacturer Narrative
Additional information: lot code #.An event regarding dislocation involving an adm liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: the adm liner with catalog number 1236-2-244 and lot 282084 was returned for evaluation.Damage was visible on the rim of the insert.Material evaluation was completed and indicated the following comments: damage consistent with the implantation/explantation process was observed on the distal rim of the insert, no materials or manufacturing defects were observed on the surfaces examined.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: an x-ray on (b)(6) 2019, documented an intraprosthetic dislocation of the mdm construct with migration of the stem in superior direction.Cup shell and stem position remain unchanged from previous descriptions because retained during revision surgery in 2017 with only conversion of the bearing in the trident shell for an mdm construct with new v40 22-mm/+3 femoral head.A second revision surgery was performed on (b)(6) 2019 with exchange of the mdm bearing for a constrained cup insert system with new v40 22-mm/+0femoral head.The new arthroplasty condition was documented on post revision x-ray on (b)(6) 2019.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: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the adm liner with catalog number 1236-2-244 and lot 282084 was returned for evaluation.Damage was visible on the rim of the insert.Material evaluation was completed and indicated the following comments: damage consistent with the implantation/explantation process was observed on the distal rim of the insert, no materials or manufacturing defects were observed on the surfaces examined.A review of the provided medical records and x-rays by a clinical consultant indicated: an x-ray on (b)(6) 2019, documented an intraprosthetic dislocation of the mdm construct with migration of the stem in superior direction.Cup shell and stem position remain unchanged from previous descriptions because retained during revision surgery in 2017 with only conversion of the bearing in the trident shell for an mdm construct with new v40 22-mm/+3 femoral head.A second revision surgery was performed on (b)(6) 2019 with exchange of the mdm bearing for a constrained cup insert system with new v40 22-mm/+0femoral head.The new arthroplasty condition was documented on post revision x-ray on (b)(6) 2019.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.

• Brand Name: RESTORATION ADM X3 INS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8619241
• Report Number: 0002249697-2019-01972
• Device Sequence Number: 13982660
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 282084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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