MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 8 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: 12/14 articul 40mm m spec+15.5; unknown hip acetabular liner; unknown hip acetabular cup; tri-lock bps sz 8 hi offset.
Event or Problem Description
It was reported that initially the patient had a trilock stem with an asr cup.The asr cup was revised a few years ago and a pinnacle cup with a 40 +15.5 metal head was implanted.The patient was revised to remove a trilock stem which had a trunion that fractured off along with the 40 mm head attached to it.A biomet arcos stem was then implanted.Doi: (b)(6) 2011- head; doi: (b)(6) 2009 - stem; dor: jul 18, 2018; right hip.
Additional Manufacturer Narrative
Product complaint # = > pc(b)(4) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: (b)(6) articul 40mm m spec+15.5; unknown hip acetabular liner; unknown hip acetabular cup; tri-lock bps sz 8 hi offset.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history review: dhr and addendum were reviewed for the product.The addendum was to associated to nonconformance records to the dhr.Ncrus-(b)(4) was for dimensionally undersized necks and ncrus-(b)(4) was for the threaded driver hole being too deep.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 8 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7788595
• Report Number: 1818910-2018-66847
• Device Sequence Number: 16755928
• Product Code: KWA
• UDI-Device Identifier: 10603295001102
• UDI-Public: 10603295001102
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101214080
• Device Lot Number: C22FV1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/17/2018; 09/10/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 08/22/2018; 09/11/2018
• 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: Required Intervention
• Patient Age: 58 YR