MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SCREW,6.5MM DIA,25MM LG; BONE SCREWS AND PINS : SCREWS

Model Number	55-6072
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
The primary surgery was performed on (b)(6) 2008 via tha for the patient's right hip joint.Post-operative progress was good.It was reported that the patient had a pain and insensitivity at the most recent regular outpatient visit.The surgeon checked by x-ray, he found bone atrophy at acetabular side and fracture at floor of the acetabulum.There was also loosening of the cup (the cup was manufactured by kyocera.).The revision surgery was performed on (b)(6) 2020 due to loosening of the cup and armd.The surgeon found that there was black powder at head-neck junction, the breakage of the screw (p/n: 556071), deformation and discoloration of the joint capsule.The surgeon replaced the cup, the stem and the head.He remained the sleeve and broken end of the screw in the body.He remained the broken screw because he could not remove it from the bone.The surgery was completed without any surgical delay.The surgeon commented that the cause of this event was problems with the sliding surface and head-neck junction.The surgeon will keep the patient under observation.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a worldwide complaint database search did find one additional related report involving pain against the provided product code/lot code combination. per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.A records review will not be performed at this time. .

• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10951572
• Report Number: 1818910-2020-26278
• Device Sequence Number: 3230304
• Product Code: LPH
• UDI-Device Identifier: 10603295175926
• UDI-Public: 10603295175926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951000.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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 Model Number: 55-6072
• Device Catalogue Number: 556072
• Device Lot Number: 4276072F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9/10 ULTAMET 36MM HEADS +0; KYOCERA; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE-A SCREW 6.5X20; S-ROM*SLEEVE PRX ZTT, 16B-SML; SROM 9/10 16X11X130 36
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 58