MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 1236-2-848

Device Problems Material Deformation (2976); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Catalog numbers and lot codes of other devices listed in this report: unknown metal femoral head lot unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported the patient's left hip was revised after complaint of pain.Intra-operatively, it was reported that the head was impinging on the poly insert, and that the insert was deformed.It is unknown if either observation caused or was a result of the other.The head and poly were revised.Rep confirmed he can provide pictures, the explants are allegedly available for return, and also confirmed that otherwise, no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding damage involving an adm liner was reported.The event was confirmed via visual inspection of the returned devices.Method & results: device evaluation and results: visual inspection: visual inspection indicates that the edges of the liner were deformed.The observed damage is consistent with stem impingement.Material analysis: material analysis is not performed as this is not related to material integrity.Damage consistent with stem impingement.Functional inspection: not performed as the functional aspects are not in question.Dimensional inspection: not performed as the dimensional aspects are not in question.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot.Conclusion: it was reported that the patient¿s left hip was revised due to pain.Intra-operatively, it was observed that the liner was deformed.Visual inspection of the returned device confirmed the presence of deformation damage on the liner, consistent with stem impingement.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported the patient's left hip was revised after complaint of pain.Intra-operatively, it was reported that the head was impinging on the poly insert, and that the insert was deformed.It is unknown if either observation caused or was a result of the other.The head and poly were revised.Rep confirmed he can provide pictures, the explants are allegedly available for return, and also confirmed that otherwise, no further information will be released by the hospital or surgeon.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12018732
• MDR Text Key: 261508478
• Report Number: 0002249697-2021-01043
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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 Expiration Date: 06/30/2016
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 37158201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2011
• 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: 75 YR
• Patient Sex: Male