MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ7 STD OFF; HIP FEMORAL STEM

Catalog Number	157002135
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/23/2018
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.
Event or Problem Description
Der stated that patient came back 1 week post op with a medial calcar fracture.The summit stem subsided causing the patient to dislocate.They removed the stem and head and replaced with a recalim modular stem.The cup and liner appeared to be in good positioning so we left those in place.It was also indicated that there was loosening at the bone to implant interface.Doi: (b)(6) 2018; dor: (b)(6) 2018; unknown side.No surgical delay.
Additional Manufacturer Narrative
(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ7 STD OFF
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7272752
• Report Number: 1818910-2018-53471
• Device Sequence Number: 11023873
• Product Code: LPH
• UDI-Device Identifier: 10603295059486
• UDI-Public: 10603295059486
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 157002135
• Device Lot Number: HG0117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/09/2018
• 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: 79 YR
• Patient Weight: 68