ZIMMER SWITZERLAND MANUFACTURING GMBH COCR HEAD, XL, 32/+8, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS
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Catalog Number 01.01012.328 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Ossification (1428); Bacterial Infection (1735); Pain (1994); Osteolysis (2377)
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Event Date 06/01/2010 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - medical devices: original m.E.Muller, stem, pt-10, standard, straight, cemented, 12.5, taper; item# 12.00.29-125; lot# 2439966.G2 - foreign: germany.Multiple mdr reports were filed for this event, please see associated report: 0009613350-2023-00428.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient underwent a revision surgery approximately two years after initial implantation due to pain and infection.During the revision, the surgeon noted heterotopic ossification, osteolysis of the acetabulum and loosening of the femoral stem.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.H6: investigation findings code: malfunction observed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A review of the sterilization certificate confirmed no abnormalities or deviations.The reported products were reviewed for compatibility with no issues noted.However, as the liner and shell are unknown, the compatibility of the entire system could not be verified.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.With the available information, a definitive root cause could not be determined for the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information at this time.
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Search Alerts/Recalls
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