MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/64; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number	1236-2-864
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the biolox head from the adm/ mdm poly insert.The devices were revised to a universal biolox head with sleeve and a new adm poly.Rep provided the primary usage sheet and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding revision due to disassociation is reported involving adm insert.The event description of disassociation was not confirmed.Method & results: product evaluation and results: product inspection - ma - material analysis is not performed as disassociation is not related to material integrity issue.Damage consistent with explantation.Visual inspection - as per the provided picture, nothing noteworthy can be noticed in the device except a few scratches around its rim.Functional and dimensional analysis could not be performed as device is not received in damage state.Clinical review: no medical records were available for clinician review.-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.Conclusions: the event was reported about revision due to disassociation involving adm insert.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the biolox head from the adm/ mdm poly insert.The devices were revised to a universal biolox head with sleeve and a new adm poly.Rep provided the primary usage sheet and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation is reported involving an adm insert.The event was not confirmed.Method & results: product evaluation and results: nothing noteworthy can be noticed in the device except a few scratches around its rim.Pictures are also attached for further reference.Material analysis is not performed as disassociation is not related to material integrity issue.Damage consistent with explantation.Clinical review: a review of the provided medical records by a clinical consultant stated the following comment: "this case was previously reviewed and reported on by me under pi - 2468438, and other than restating the event description, no new clinical evidence is offered.It is still not possible to confirm the event descriptions nor prepare a medical report for this case." -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.Conclusions: it was reported that the patient's hip was revised due to dissociation of the biolox head from the adm/ mdm poly insert.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.Further information is needed to complete the investigation for determining its root cause.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the biolox head from the adm/ mdm poly insert.The devices were revised to a universal biolox head with sleeve and a new adm poly.Rep provided the primary usage sheet and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: RESTORATION ADM X3 INS 28/64
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10238336
• Report Number: 0002249697-2020-01377
• Device Sequence Number: 689383
• Product Code: MEH
• UDI-Device Identifier: 04546540639059
• UDI-Public: 04546540639059
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 1236-2-864
• Device Catalogue Number: 1236-2-864
• Device Lot Number: 38456601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 09/11/2020; 05/27/2021
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 10/07/2020; 06/21/2021
• 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: 75 YR