MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 36MM, +5MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6565-0-236
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that 11 devices were manufactured and accepted on 21-jul-2015 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.Not available.
Event or Problem Description
Patient presented acutely to hospital on (b)(6) 2018 with pain, unable to weight bear and dislocated hip.It was noted that exeter stem was broken at neck level.Initial operation occurred 9 years earlier.Revision surgery was performed at (b)(6) hospital on (b)(6) 2018 and broken stem (44, #4) along with 36+5 alumina ceramic head and 36g alumina ceramic liner were removed.Cement in cement revision of stem performed (50, #2) and new 32+0 biolox ceramic head and 32g 0 degree x3 liner implanted.Revision surgeon said that patient had previously described a ¿grinding sensation¿ in the hip prior to break.Update 17 december, 2018: initial reporter stated "the revision surgeon wanted me to note that a lot of the damage to these occurred during the removal of these and there was no visible sign of impingement that he could see intraoperatively.".
Additional Manufacturer Narrative
An event regarding dislocation involving a ceramic head was reported.Dislocation was not confirmed however, material analysis confirmed wear on the device.Method & results -product evaluation and results: visual inspection of the device was performed as part of material analysis report dated 19 march, 2019.Metal transfer markings were observed on the head, consistent with contact against a metal object.Additionally, a wear scar was observed on the articulating surface of the head.Damage was observed on the distal surface of the head, consistent with contact against a hard object.Material analysis of the returned device noted the following: based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: review of these records confirm fracture of the exeter stem occurred, however, the root cause cannot of the pain be determined as insufficient information was available.The index surgery was uneventful and without complication.Post operative xrays have normal appearance showing a well fixed implants in expected position and orientation.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient presented acutely to hospital on (b)(6) 2018 with pain, unable to weight bear and dislocated hip.It was noted that exeter stem was broken at neck level.Initial operation occurred 9 years earlier.Revision surgery was performed at tauranga hospital on 6/12/18 and broken stem (44#4) along with 36+5 alumina ceramic head and 36g alumina ceramic liner were removed.Cement in cement revision of stem performed (50#2) and new 32+0 biolox ceramic head and 32g 0 degree x3 liner implanted.Revision surgeon said that patient had previously described a ¿grinding sensation¿ in the hip prior to break.Update 17 december, 2018: initial reporter stated "the revision surgeon wanted me to note that a lot of the damage to these occurred during the removal of these and there was no visible sign of impingement that he could see intraoperatively.".

• Brand Name: ALUMINA V40-FEMORAL HEAD 36MM, +5MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8214786
• Report Number: 0002249697-2019-00025
• Device Sequence Number: 1987915
• Product Code: JDI
• UDI-Device Identifier: 04546540390516
• UDI-Public: 04546540390516
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: No Information
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 6565-0-236
• Device Lot Number: 26639302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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
• Patient Age: 69 YR
• Patient Weight: 73