MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOSTOP G CEM RESTR 12MM; DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG

Model Number	5463-12-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
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
We had a biostop cement restrictor break into two pieces and could only partially be removed during hip replacement surgery on the 15th june.The surgery was successfully completed after a 20 minute delay.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : the complaint states: ¿we had a biostop cement restrictor break and only partially be removed during hip replacement surgery on the 15th june.The lot number was 20j0103011 and the sn is (b)(6).We did not keep the broken parts for testing.¿ additional information was received which states: 1.Which part of the biostop g cem restr 12mm broke? it snapped in half ¿ half remained attached to the introducer.2.Did it break into 2 or more pieces? how many? 2 pieces.3.Were all pieces retrieved from the patient? the pieces could not be retrieved.4.Was surgery time extended? if yes, what was the duration of the delay? the surgery time was extended by approx.20mins.5.Was there any adverse consequences that affected the patient because of the reported event? none at this time.The product was not available for investigation and there are no other investigation inputs received.The complaint description cannot be confirmed with the information available.Root cause cannot be determined with the information available.Dva-107701-fde rev 9 was reviewed (see attachment ¿pc-(b)(6) extract from dva-107701-fde.Pdf).Failure of mechanical properties for restrictors is included as possible failure mode.In each case the risk is considered as low as possible and cannot be further mitigated.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as required.Device history lot : device history is not available for review as product is manufactured externally.

• Brand Name: BIOSTOP G CEM RESTR 12MM
• Common Device Name: DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12134825
• Report Number: 1818910-2021-14679
• Device Sequence Number: 14498192
• Product Code: LZN
• UDI-Device Identifier: 10603295174561
• UDI-Public: 10603295174561
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5463-12-000
• Device Catalogue Number: 546312000
• Device Lot Number: 20J0103011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: BIOSTOP G CEM RESTR 12MM; BIOSTOP G CEM RESTR 12MM